BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3071229 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19875
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. 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 MAY HAVE BEEN CAUSED BY A BULKY CHUNK OF CALCIUM ON A NATIVE LEAFLET OVERHANGING A LEAFLET ON THE SAPIEN VALVE. 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, AFTER DEPLOYING A 23MM SAPIEN VALVE 50:50 ACROSS THE NATIVE AORTIC ANNULUS VIA A TRANSAPICAL APPROACH, WIDE OPEN CENTRAL AORTIC INSUFFICIENCY (CAI) WAS NOTED. POST DILATION WAS PERFORMED, BUT THE CAI REMAINED UNCHANGED. THE PATIENT BECAME HYPOTENSIVE AND WAS PUT ON CARDIOPULMONARY BYPASS (CPB). A SECOND SAPIEN VALVE WAS THEN IMPLANTED WITHIN THE FIRST VALVE, RESOLVING THE CAI. THE NATIVE AORTIC ANNULAR DIAMETER WAS 22MM. THE NATIVE VALVE WAS MODERATELY CALCIFIED WITH BULKY CALCIFICATION ON ONE LEAFLET. THE PATIENT HAD A PROMINENT SEPTAL BULGE. THE PATIENT'S EJECTION FRACTION (EF) WAS 35%. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. THERE WAS NO LOSS OF PACING CAPTURE, AND VENTILATION WAS HELD DURING DEPLOYMENT. PER REPORT, THE PERCEIVED CAUSE OF THE EVENT WAS A NATIVE LEAFLET WITH A BULKY CHUNK OF CALCIUM OVERHANGING A LEAFLET ON THE SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171368 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention