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

Model Number PERCEVAL 25 MM VALVE

Device Problem Insufficient Information (3190)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that one day post implant of a suture-less bioprosthetic heart valve, patient developed complete heart block with ventricular escape rate of 30 beats per minute.A permanent pacemaker was inserted four days post implant, and the patient remained stable.No additional 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: PERCEVAL
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17535195
• MDR Text Key: 321148255
• Report Number: MW5142094
• 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: 04/12/2018

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
• Device Model Number: PERCEVAL 25 MM VALVE
• Patient Sequence Number: 1