MAUDE Adverse Event Report: EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROTHESIS; REPLACEMENT HEART-VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pleural Effusion (2010)

Event Type  Injury  

Event Description

Medtronic received information that four days post implant of an edwards magna ease pericardial bioprosthetic valve, chest xray revealed small bilateral pleural effusions.No intervention was required.No 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 EASE PERICARDIAL BIOPROTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 17534974
• MDR Text Key: 321145052
• Report Number: MW5141874
• 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: 08/09/2016

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