MAUDE Adverse Event Report: ABBOTT MEDICAL/ ST. JUDE MEDICAL, INC. 25MM MECHANICAL AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number 25AGFN-756

Patient Problem Failure of Implant (1924)

Event Date 08/07/2023

Event Type  malfunction  

Event Description

Aortic valve was implanted in a patient and did not function properly.Required explantation by surgeon.Valve was returned to manufacturer for further investigation.

• Brand Name: 25MM MECHANICAL AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL/ ST. JUDE MEDICAL, INC.
• MDR Report Key: 17682743
• MDR Text Key: 322742152
• Report Number: MW5145136
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25AGFN-756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male