Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

Background/purposeThe MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania).Methods/materialsPost-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports.ResultsOf the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).ConclusionsOur analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD.     

Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

Background/purposeThe Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited.Methods/materialsWe analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports.ResultsOf the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3).ConclusionsOur analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes.     

Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database

Background/purposeOptical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use.Methods/materialsThe MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed.ResultsOf the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported.ConclusionsFindings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.     

Adverse Events Following Transcatheter Edge-to-Edge Repair (TEER) Using MitraClip: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Registry

ObjectiveThe MitraClip from Abbott is FDA approved intracardiac implantable device for transcatheter edge-to-edge repair (TEER). Despite a few previously published studies, there is limited safety data for its use in clinical practice, hence, we designed this study using data obtained from a safety nationwide database to demonstrate the safety profile of MitraClip.MethodsThe first two of the five authors independently queried all reported adverse events from the United State Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] registry from January 2014 to December 2020. The primary end point was trend in reported fatal events obtained from this database. The secondary end points included the causes of reported nonfatal reports from the MAUDE registry. The trend of reported fatal events was assessed using the Cochran Armitage trend test over the period of the study.ResultsDuring the study period, subjects included 3370 patients whose MitraClip-associated adverse events were reported and captured by MAUDE registry. Of these, 211 were fatal and 3159 nonfatal events. Fatal event reports resulted deaths and reported nonfatal events were from injuries and device system malfunction. This study demonstrated an initial upward trend from 2014 to 2015 then a subsequent statistically significant downward trend in reported fatal events from 2015 to 2020 (Cochran-Armitage test P = 0.039). The peak proportion of reported fatal events occurred in 2015, (n = 44; representing 1.25% of reported adverse events) and lowest proportion of reported fatal events took place in 2020 (n = 19; representing 0.56% of reported adverse events). The most reported nonfatal events were from malfunctioning of MitraClip system (n = 1170; representing 37% of reported nonfatal events), new unremarkable repolarization abnormalities on periprocedural EKG (n = 864; representing 27% of reported nonfatal events), leaflet rupture (n = 651; representing 21% of reported nonfatal events), and cardiogenic shock (n = 170; representing 5% of reported nonfatal events).ConclusionsThis analysis of the MAUDE Registry indicated, especially within the confines of this study's limitations and poor data quality of information, an apparent downward trend of reported fatal events over the study period. Even though conclusive attributions cannot be made regarding this important finding, perhaps, this points to early evidence of a potential institutional or operator learning curve with this device. However, in view of the inferior quality of the data accrued from the MAUDE Registry, more high-precision studies are needed to better understand these changes, as the utility of MitraClip, becomes more established in clinical practice.     

Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database

Background/purposeWe aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters.Methods/materialsThe US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events.ResultsOf the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon.ConclusionsFindings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters.SummaryTo assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.     

Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database

Background/purposeCoronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.Methods/materialsWe queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis.ResultsPercentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery.ConclusionAn analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.     

Major Complications Associated with Transcatheter Atrial Septal Occluder Implantation: A Review of the Medical Literature and the Manufacturer and User Facility Device Experience (MAUDE) Database

Objective. To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. Design. The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. Outcome. The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.     

Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation

Background/PurposeWe assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited.Methods/MaterialsThe MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis.ResultsPercentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage).ConclusionsAnalysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology.SummaryAn analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator.     

Complications and Failure Modes of Covered Coronary Stents: Insights From the MAUDE Database

BackgroundData on the mechanisms of failure of covered coronary stents [Graftmaster, PK Papyrus] are limited.MethodsWe queried the “Manufacturer and User Facility Device Experience” (MAUDE) database between August 2018 (when the PK Papyrus stent was FDA approved) and December 2020 for reports on covered coronary stents.ResultsWe identified 299 reports in the MAUDE database (after excluding duplicates, peripheral vascular reports, and incomplete records) (Graftmaster n = 225, PK Papyrus n = 74). The most common mechanism of failure of covered stents was failure to deliver the stent (46.2%), followed by stent dislodgement (22.4%) and failure to seal the perforation (19.7%). Failure to deliver the stent was more often reported with Graftmaster compared with PK Papyrus (59.1% vs. 6.8%, p < 0.001). Stent dislodgement was more often reported with PK Papyrus compared with Graftmaster (75.7% vs. 4.9%, p < 0.001) and was managed by device retrieval or by crushing the stent.ConclusionsThe most common failure mechanisms of covered stents are failure of delivery, stent dislodgement, and failure to seal the perforation. Failure of delivery was more common with Graftmaster, while stent dislodgement was more common with PK Papyrus. Further improvements in covered stent design are needed to optimize deliverability and minimize the risk of complications.     

Complications and Failure Modes of Polymer-Jacketed Guidewires; Insights From the MAUDE Database

BackgroundThe modes of failure of coronary polymer-jacketed guidewires have received limited study.MethodsWe queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports.ResultsThe most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection).ConclusionsThe most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.     

Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016

1 Background

Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long‐term oral anticoagulation (OAC).

2 Objective

We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

3 Methods

The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT^® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN? (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices.

4 Results

LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre‐ and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction.

5 Conclusions

MAUDE‐reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.     

Complications of the MANTA Closure Device: Insights From MAUDE Database

BackgroundThe collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting.MethodsWe queried the “Manufacturer and User Facility Device Experience” MAUDE database between February 2019 and December 2020 for reports on MANTA device.ResultsWe identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03).ConclusionsThe most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.     

Complications of Penumbra Indigo Aspiration Device in Pulmonary Embolism: Insights From MAUDE Database

BackgroundThe Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) is a suction embolectomy device that was cleared by the Food and Drug Administration for use in acute pulmonary embolism (PE). While this device has proven to be safe in clinical trials, real-world data are minimal.MethodsThe “Manufacturer and User Facility Device Experience” MAUDE database was queried for reports of Penumbra indigo system from January 2020 to August 2021.ResultsA total of 2118 reports were found during the study period. After the exclusion of duplicate and incomplete reports as well as reports not related to PE, our final cohort included 67 reports related to Penumbra indigo device failure. The most common failure mode was Lightning unit malfunction (35.8%, n = 24) followed by rotating hemostasis valve malfunction (31.3%, n = 21). Three (4.5%) patients died; two (3%) from fatal pulmonary vessel perforation, and one from fatal right-sided heart failure. There was one case (1.5%) of pericardial effusion, while there were no cases of hemoptysis or blood transfusion.ConclusionThe overall number of reports in the MAUDE registry related to the Penumbra Indigo aspiration system is small (67 reports in 20 months). The most common reported failure mode was Lightning unit malfunction. These data serve to inform operators about potential issues when using the Penumbra Indigo thrombus aspiration system and identify areas on which to focus further device iteration.