MAUDE Adverse Event Report: UNKNOWN BIOPROSTHETIC VALVE; HEART-VALVE, MECHANICAL

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020)

Event Type  Injury  

Event Description

Medtronic received information that this bioprosthetic valve, implanted less than one month, was explanted due to paravalular leak.I was reported that the surgeon had not observed any gaps in the sutures.In addition, they had used another manufacturer's knot pusher (cor knot).A couple of the clips did not seem to be completely tightened; however, the surgeon was hesitant to blame the knot pusher for the problem.It was reported that the patient is suffering from pulmonary edema with shortness of breath post-operatively, and the explanted valve will be returned for analysis.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BIOPROSTHETIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531517
• MDR Text Key: 321134554
• Report Number: MW5138431
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 02/25/2013

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