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

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problems Ischemia (1942); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/01/2018

Event Type  Death  

Manufacturer Narrative

The investigation was unable to determine a cause for the reported entrapment of device, mitral regurgitation (mr), mitral stenosis, ischemia and death.Death, mr, mitral stenosis and ischemia are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported surgical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.Date of event, implant date: dates estimated.The udi number is not known as the part and lot number were not provided.The additional patient effects reported in the article are captured under a separate medwatch report number.Article titled, "randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients.".

Event Description

This is filed to report patient deaths.This research article was a meta-analysis study designed to evaluate the safety and effectiveness of the pascal system compared to the mitraclip system in patients with significant symptomatic degenerative mitral regurgitation (dmr).Complications identified in the study included: patient deaths, severe bleeding, mitral stenosis, mesenteric ischemia, device entrapment, leaflet perforation and surgical intervention.In conclusion, the excellent safety and effectiveness outcomes in both treatment groups are indicative of the tremendous improvements in contemporary mitral valve transcatheter edge-to-edge repair technology as well as operator skill and experience and will expand treatment options for patients.Details are listed in the attached article titled, "randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients".No additional information was provided.

• 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: 15740482
• MDR Text Key: 303133926
• Report Number: 2135147-2022-01951
• 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: 11/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• 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): Death
• Patient Age: 81 YR
• Patient Sex: Male