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 Atrial Fibrillation (1729); Cardiac Arrest (1762); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Renal Failure (2041); Perforation of Vessels (2135); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This is filed to report mitral stenosis, mitral regurgitation, atrial fibrillation, stroke, surgical intervention, unexpected medical intervention, vascular perforation, bleeding, cardiac arrest, dialysis, myocardial infarction, endocarditis, heart failure, and hospitalization.This research article was a meta-analysis designed to evaluate outcomes of transcatheter mitral valve repair for degenerative mr.Complications identified in the study included: death, mitral stenosis, mitral regurgitation, atrial fibrillation, stroke, surgical intervention, unexpected medical intervention, vascular perforation, bleeding, cardiac arrest, dialysis, myocardial infarction, endocarditis, heart failure, hospitalization.Device issues mentioned included single leaflet device attachment (slda), and complete clip detachment.In conclusion, for patients undergoing transcatheter mitral valve repair for isolated degenerative mr, the procedure was safe despite advanced age and comorbidities.Details are listed in the attached article titled, "transcatheter mitral valve repair for degenerative mitral regurgitation".

Manufacturer Narrative

Date of event is estimated.The implant date is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported mitral stenosis associated with increased gradient, the reported mitral valve insufficiency/ regurgitation (recurrent mr), the reported atrial fibrillation, the reported cerebrovascular accident associated with stroke, the reported perforation of vessels (surgical procedure), the reported hemorrhage (surgical procedure) associated with bleeding, the reported cardiac arrest, the reported myocardial infarction, the reported renal failure, the reported endocarditis, the reported heart failure/congestive heart failure, and the reported death / expired, could not be determined.The reported embolism/embolus was due to the clip expulsing.The cause of the reported expulsion (ccd/gripper line removed) associated with clip expulsion, and the reported incomplete coaptation associated with slda, could not be determined.The reported patient effects of mitral stenosis, mitral regurgitation, cerebrovascular accident, perforation of vessels, hemorrhage, myocardial infarction, renal failure, myocardial infarction, endocarditis, heart failure, atrial fibrillation, cardiac arrest, death, and embolism, the reported surgical intervention, unexpected medical intervention, unexpected medical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17163767
• MDR Text Key: 317487247
• Report Number: 2135147-2023-02664
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/20/2023

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: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization