MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 SYSTEM; MITRAL VALVE REPAIR DEVICES

Patient Problems Dyspnea (1816); Fatigue (1849); Failure of Implant (1924); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/18/2023

Event Type  Injury  

Event Description

Mitral valve clip on (b)(6) 2023 was successful.Valve clip failed on (b)(6) 2023 requiring me to be placed on a heart pump for 5 days, a repeat surgery and a total of 20 days of hospitalization.Second clip was not as successful, leaving me with a moderate/severe leak of the mitral valve.This causes extreme shortness of breath when walking and inability to walk any short distance without resting.I am no longer able to bath or dress unassisted.In short, i am in worse shape than i was prior to the first mitral valve clip on (b)(6) 2023.Reference report: #mw5149749.

• Brand Name: MITRACLIP G4 SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18443291
• MDR Text Key: 332143288
• Report Number: MW5149750
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Patient Sequence Number: 1
• Treatment: CRANBERRY SUPPLEMENT.; DIURETICS.; MAGNESIUM.; XARELTO.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White