MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Stroke/CVA (1770); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2018

Event Type  Injury  

Event Description

The article, "safety and effectiveness of concomitant mitral transcatheter edge-to-edge repair and left atrial appendage closure", was reviewed.The article presented a retrospective, single center study aimed at reporting safety and mid-term outcomes of concomitant mitral transcatheter edge-to-edge repair (m-teer) and left atrial appendage closure (laac) procedures, comparing them to those of patients undergoing isolated m-teer throughout the same period.Devices included in the study were amplatzer amulet, watchman flx, and mitraclip.The article concluded that patients with concomitant mitral regurgitation and atrial fibrillation and eligible for m-teer and laac treatment, a combined approach of m-teer and laac was as safe as an m-teer-alone strategy and associated with lower minor bleeding at 1 year.[the primary and corresponding author was marco barbanti, division of cardiology, a.O.U.Policlinico ¿g.Rodolico san marco¿, 95123 catania, italy, with corresponding email: mbarbanti83@gmail.Com] the time frame of the study was from january 2018 to december 2022.A total of 99 patients were included in the study.Of the patients who underwent laac procedure, only one received an amplatzer amulet.Of the patients who underwent m-teer, 97.9% received a mitraclip device.The average age was 79 years and the majority gender was male.Comorbidities included hypertension, diabetes mellitus, dyslipidemia, chronic kidney disease, prior stroke, prior transient ischemic attack, prior percutaneous coronary intervention, prior coronary artery bypass graft, coronary artery disease, prior myocardial infarction, degenerative/functional mitral regurgitation.(b)(4), unk amplatzer amulet.Peri- and post-procedural complications included device related thrombus, hematoma.(b)(4), unk mitraclip delivery system.Intra procedure complications included pseudoaneurysm, hematoma, surgical intervention, fistula, unexpected medical intervention, mitral stenosis, clip detachment, poor imaging.Peri and post procedural complications included death, stroke, systemic embolism, bleeding/hemorrhage, heart failure, hospitalization, thrombus.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effect of death and malfunctions reported in the article are captured under separate medwatch reports.Literature attachment: article title "safety and effectiveness of concomitant mitral transcatheter edge-to-edge repair and left atrial appendage closure.".

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) and complaint history reviews were not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported expulsion and poor image resolution were unable to be determined.Additionally, the reported patient effects of death/expired, aneurysm, cerebrovascular accident, hematoma, fistula, hemorrhage, embolism, heart failure, mitral stenosis, and thrombus, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported patient effects of death/expired, aneurysm, cerebrovascular accident, hematoma, fistula, hemorrhage, embolism, heart failure, mitral stenosis, and thrombus cannot be determined.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Literature attachment: article title ¿safety and effectiveness of concomitant mitral transcatheter edge-to-edge repair and left atrial appendage closure".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19014801
• MDR Text Key: 339083388
• Report Number: 2135147-2024-01451
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention