BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3110214 · Received May 13, 2013

    Report

    Report Number
    2015691-2013-20069
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE AND THE PATIENT SCREENING MANUAL, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. FACTORS THAT CAN CONTRIBUTE TO IMPAIRED LEAFLET COAPTATION INCLUDE OVER INFLATION OF THE DEPLOYMENT BALLOON AND NATIVE LEAFLET OVERHANG. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, PER REPORT, THE CAI WAS CAUSED BY NATIVE LEAFLET OVERHANG WHICH PREVENTED ONE OF THE SAPIEN VALVE LEAFLETS FROM COAPTING PROPERLY. IT IS POSSIBLE THAT THE NOTED BULKY CALCIFICATION ON THE NATIVE VALVE CONTRIBUTED TO THE CAI AND POSSIBLE IMPAIRED COAPTATION OF THE SAPIEN VALVE LEAFLETS. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, FOLLOWING DEPLOYMENT OF A 23MM SAPIEN VALVE VIA A TRANSFEMORAL APPROACH, MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI) WAS NOTED ON TEE. PER REPORT, THE CAI WAS CAUSED BY NATIVE LEAFLET OVERHANG, WHICH PREVENTED ONE OF THE SAPIEN VALVE LEAFLETS FROM COAPTING PROPERLY. THE PHYSICIAN DECIDED TO IMPLANT A SECOND SAPIEN VALVE WITHIN THE FIRST. DURING DEPLOYMENT OF THE SECOND SAPIEN VALVE, THE DELIVERY BALLOON RUPTURED HOWEVER THE SAPIEN VALVE STAYED IN PLACE. VIA TEE, THERE WAS NO CENTRAL OR PARAVALVULAR LEAK AND THE VALVE APPEARED WELL OPPOSED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE NATIVE AORTIC ANNULUS MEASURED 20MM BY TEE AND 20X21 (AREA 388) BY CT. THERE WAS MODERATE, BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE. THE NATIVE AORTIC ROOT WAS MILDLY CALCIFIED. THE LENGTH OF THE NATIVE AORTIC VALVE LEAFLETS IS NOT KNOWN. THE SAPIEN VALVE WAS POSITIONED AND IMPLANTED IN A 50:50 POSITION ACROSS THE NATIVE AORTIC ANNULUS. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210457 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention