MAUDE Adverse Event Report: BAXTER BAXTER AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number P/N 271056

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Medtronic received information that a core valve was implanted valve-in-valve in a failed baxter bioprosthetic aortic valve.The baxter aortic valve was implanted in the l 990's.No further information was provided.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BAXTER AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17536033
• MDR Text Key: 321061942
• Report Number: MW5142925
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: P/N 271056
• Patient Sequence Number: 1