BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3092284 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19993
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, AORTIC INSUFFICIENCY IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO RELEASE FOR DISTRIBUTION. EVERY VALVE IS TESTED FOR PROPER COAPTATION UNDER NOMINAL SIMULATED PATIENT TEST CONDITIONS IN A PULSE DUPLICATOR TO CONFIRM THAT THE VALVE LEAFLETS OPEN AND CLOSE PROPERLY. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A COMPLAINT OF NON-FUNCTIONING LEAFLET, INCLUDING DEPLOYMENT OF THE VALVE TOO VENTRICULAR IN COMBINATION WITH NATIVE LEAFLET OVERHANG, LONG NATIVE LEAFLETS OVERHANGING THE PROSTHETIC VALVE, LEAFLET IMPINGEMENT DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. IN THIS CASE, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. PER THE INFORMATION RECEIVED, THE VALVE WAS DEPLOYED AS RECOMMENDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THAT POST DEPLOYMENT OF A SAPIEN VALVE IN A 50/50 POSITION, TEE SHOWED SEVERE AORTIC INSUFFICIENCY (AI) WITH A MILD PARAVALVULAR LEAK (PVL). THE PHYSICIAN USED A PIGTAIL CATHETER TO MANIPULATE THE LEAFLETS WITHOUT SUCCESS. A SECOND SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED 50:50 IN THE EXISTING VALVE WITHOUT INCIDENT WITH A FINAL RESULT OF NO PVL OR CENTRAL AI. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL. THE ANNULAR DIAMETER MEASURED 24 MM BY TEE. THE AORTIC VALVE AND LEAFLET CALCIFICATION WAS DESCRIBED AS SEVERE AND THE AORTIC ROOT CALCIFICATION WAS MILD. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE DESCRIBED AS GOOD. DURING VALVE DEPLOYMENT VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194272 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention