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

Model Number CDS0701-XTW

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/24/2022

Event Type  Death  

Event Description

Abbott mitraclip g4 system failed.Non smoker, non drinker.

• Brand Name: ABBOTT MITRACLIP G4 SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 16618178
• MDR Text Key: 312119899
• Report Number: MW5115966
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)220514(10)10515R285
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: 000311440
• Device Lot Number: 10515R285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 10MG, ; ATORVASTATIN 40MG; CALCIUM 600MG; CLOPIDOGREL 75MG; ELIQUJS 2.5 MG; ENTRESTO 24MG; FUROSEMIDE 20MG; METOPROLOL 100MG; PANTOPRAZOLE 40MG; VITAMIN D3 5000
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White