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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemothorax (1896)

Event Type  Injury  

Event Description

Medtronic received information that one day following the implant of an edwards perimount magna valve, a right hemathorax was noted.Subsequently, emergency surgical re-exploration was performed and the hemothorax was drained.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 MAGNA VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17537423
• MDR Text Key: 321068622
• Report Number: MW5144301
• 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: 04/17/2017

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