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

Model Number LARGE SUTURELESS BIOPROSTHESIS VALVE

Device Problem Insufficient Information (3190)

Patient Problem Heart Block (4444)

Event Date 02/21/2018

Event Type  Injury  

Event Description

Medtronic received information that the patient developed left bundle branch block post-operatively with no heart block on (b)(6) 2018.A short while after, the patient developed asystole on telemetry while in the intensive care unit.Complete heart block with no escape was noted.Patient had a short procedure for the placement of a temporary transvenous pacing wire through the right femoral vein.On (b)(6) 2018 a dual-chamber pacemaker procedure was completed, and the temporary pacing wire was removed by dr.(b)(6).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 PERCEVAL
• MDR Report Key: 17527612
• MDR Text Key: 321054644
• Report Number: MW5134544
• 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: 02/27/2018

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: LARGE SUTURELESS BIOPROSTHESIS VALVE
• Patient Sequence Number: 1