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

Model Number PERCEVAL 21MM

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that immediately post implant of a surgical sutureless bioprosthesis valve, patient had no underlying rhythm.Patient was found to be in complete heart block and physician felt a permanent pacemaker (ppm) implant was needed.Patient was dependent on temporary pacer with no underlying rhythm for 48 hours.Two days post implant, a ppm was implanted, and 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: 17530981
• MDR Text Key: 321136120
• Report Number: MW5137897
• 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: 05/17/2018

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
• Device Model Number: PERCEVAL 21MM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1