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

Device Problem Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a failed sorin mitroflow surgical valve, the cusp of the surgical valve occluded the left coronary artery.Despite cardiac massage and emergency cardiac care the patient expired.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP
• MDR Report Key: 17530329
• MDR Text Key: 321038200
• Report Number: MW5137248
• 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: 11/02/2016

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