MAUDE Adverse Event Report: SORIN GROUP MITROFLOW AORTIC PERICARDIAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a failed sorin mitroflow surgical aortic valve, a 29mm evolutr valve (b556092) was implanted successfully.No adverse patient effects were reported.Pe (b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW AORTIC PERICARDIAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP
• MDR Report Key: 17526166
• MDR Text Key: 321405427
• Report Number: MW5133106
• 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: 07/15/2016

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
• Patient Sequence Number: 1