MAUDE Adverse Event Report: SORIN PERCEVAL PERCEVAL; SIZER, HEART-VALVE, PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Medtronic received information that ten days following implantation of this bioprosthetic valve, tee showed a large circumferential posterior pericardiai effusion and the following day a pericardiai window was performed and 650 cc of serosaguineous fluid was removed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERCEVAL
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN PERCEVAL
• MDR Report Key: 17524274
• MDR Text Key: 321132360
• Report Number: MW5131221
• Device Sequence Number: 1
• Product Code: DTI
• 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: 03/21/2018

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