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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of an edwards perimount valve, complete heart block (chb) was reported and a permanent pacemaker was implanted five days later.No further adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERIMOUNT VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17533324
• MDR Text Key: 321044194
• Report Number: MW5140228
• 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: 04/24/2017

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