MAUDE Adverse Event Report: EDWARDS CARPENTIER REPLACEMENT HEART VALVE; REPLACEMENT HEART-VALVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

Medtronic received information that two days following the implant of this transcatheter bioprosthetic valve, patient went into atrial fibrillation and an amiodarone drip was started.Twelve days after the amiodarone drip treatment a permanent pacemaker was implanted.(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 CARPENTIER
• MDR Report Key: 17537637
• MDR Text Key: 321133928
• Report Number: MW5144489
• 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: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1