MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC 21 MM CARPENTIER; REPLACEMENT HEART-VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that a medtronic transcatheter bioprosthetic aortic valve was implanted into a 21mm carpentier edwards valve due to aortic regurgitation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 21 MM CARPENTIER
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17531612
• MDR Text Key: 321054720
• Report Number: MW5138525
• Device Sequence Number: 1
• Product Code: DYE
• 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: 01/03/2017

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