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

Model Number 23 MEDIUM PERCEVAL

Patient Problems Failure of Implant (1924); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that approximately 5 years and 2 months following the implant of a non-medtronic surgical aortic valve, severe aortic insufficiency and heart failure developed with an ejection fraction of 50-55%.As result, a medtronic transcatheter bioprosthetic valve was implanted valve-in-valve.No additional adverse patient effects were reported.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERCEVALL SUTURELESS AORTIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP
• MDR Report Key: 17930476
• MDR Text Key: 325718394
• Report Number: MW5146916
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 23 MEDIUM PERCEVAL
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1