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

Device Problems Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that immediately post implant of this edwards bioprosthetic aortic valve, the valve exhibited apparent prolapse of left leaflet resulting in aortic insufficiency.The valve was removed and a second valve was placed with excellent results; the aortic insufficiency was resolved.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REPLACEMENT HEART VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17535437
• MDR Text Key: 321047322
• Report Number: MW5142334
• 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: 08/17/2017

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