MAUDE Adverse Event Report: CARPENTIER EDWARDS REPLACEMENT HEART - VALVE; REPLACEMENT HEART-VALVE

Model Number UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Medtronic received information that a transcatheter bioprosthetic valve was implanted valve - in - valve into a failed 21mm carpentier edwards surgical valve.The failure mechanism of the carpentier edwards valve was not reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REPLACEMENT HEART - VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): CARPENTIER EDWARDS
• MDR Report Key: 17528687
• MDR Text Key: 321142339
• Report Number: MW5135617
• Device Sequence Number: 1
• Product Code: DYE
• 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: 07/17/2018

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: UNKNOWN
• Patient Sequence Number: 1