MalfunctionDTJ
HOLDER, HEART-VALVE, PROSTHESIS
Received Aug 12, 2023
Report MW5132423 · MDR key 17525482
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE IN A PREVIOUSLY IMPLANTED AORTIC VALVE (SORIN MITROFLOW 21), FOR UNKNOWN REASONS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. 702263009. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).