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 Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 05/01/2014

Event Type  Injury  

Event Description

This is filed to report worsened mitral regurgitation.The aim of this prospective observational study was to analyze the contribution of heart failure to the physical frailty phenotype by examining patients with heart failure before and after percutaneous mitral valve repair (pmvr) with a mitraclip or non-abbott device.Frailty according to the fried criteria (weight loss, weakness, exhaustion, slowness, and low activity) was assessed in consecutive patients before and 6 weeks after pmvr.All patients had symptomatic mitral regurgitation (mr) grade 3 or 4, and the etiology was primary cause in 88 patients, of secondary cause in 141 patients, and of mixed causes in 28 patients.It was noted that 25% of the patients died within 90 days after the procedure and 12% were newly frail post-pmvr.There was an increase of patients with post-procedure mr grade of 3-4 ( baseline: 7 no-nfrail and 4 frail; follow-up: 9 non-frail and 6 frail).Treatment of mitral regurgitation in patients with heart failure is associated with almost a halved burden of physical frailty, particularly in patients with a less advanced phenotype.This study warrants further evaluation of the concept of frailty as a primary treatment target.Details are listed in the article titled, "disentangling heart failure and physical frailty prospective study of patients undergoing percutaneous mitral valve repair.".

Manufacturer Narrative

The additional patient effect of death reported in the article is captured under a separate medwatch report.B3: date of event was estimated.D4: the udi is unknown as the part and lot numbers were not provided d6a: date of implant was estimated.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.Based on available information, the cause of the reported fatigue, death / expired, and mitral valve insufficiency/ regurgitation (worsening mr) could not be determined.The reported patient effects of death and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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: 17182585
• MDR Text Key: 317994310
• Report Number: 2135147-2023-02714
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/22/2023

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: 06/01/2023
• Initial Date FDA Received: 06/22/2023
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Female