MAUDE Adverse Event Report: SORIN SIZER, HEART-VALVE, PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that a transcatheter bioprosthetic valve was implanted valve-in-valve into a failed 21 mm sorin mitroflow aortic valve.The failure mechanism of the sorin 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: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17534801
• MDR Text Key: 321269881
• Report Number: MW5141701
• Device Sequence Number: 1
• Product Code: DTI
• 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: 04/26/2018

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
• Patient Sequence Number: 1