BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANCATHETER HEART VALVE

    MDR report key: 2661822 · Received July 19, 2012

    Report

    Report Number
    2015691-2012-17917
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 25, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO PATIENT PRIVACY LAWS IN (B)(6), THE SITE WILL NOT RELEASE THE MEDICAL RECORDS RELATED TO THIS EVENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SOB AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH, THROMBOSIS, OR IN RARE CASES A NON-FUNCTIONING LEAFLET. IN THE ABSENCE OF THE MEDICAL RECORDS RELATED TO THE EVENT, AND THE PATIENT'S MEDICAL HISTORY, THE ETIOLOGY OF THE REPORTED VALVE STENOSIS AND FIBROSIS IN THIS CASE CANNOT BE CONFIRMED. OF NOTE, THE SAPIEN VALVE IS INDICATED FOR USE IN A NATIVE AORTIC VALVE ANNULUS. IN THIS CASE, THE VALVE WAS DEPLOYED INSIDE A SURGICAL HEART VALVE, IN THE TRICUSPID POSITION. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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

    AN IMPLANT PATIENT REGISTRY (IPR) CARD (B)(6) WAS RETURNED FOR THIS PATIENT THAT INDICATED THAT A TISSUE VALVE HAD BEEN EXPLANTED. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: ON (B)(6) 2009, A SAPIEN VALVE WAS IMPLANTED IN THE TRICUSPID POSITION WITHIN A MEDTRONIC MOSAIC VALVE, WHICH HAD BECOME STENOTIC. A SECOND SAPIEN VALVE WAS DEPLOYED WITHIN THE FIRST DUE TO 3+ REGURGITATION. ON (B)(6) 2012, THE MOSIAC AND SAPIEN VALVES WERE EXPLANTED DUE TO THE SAPIEN VALVES BECOMING STENOTIC AND FIBROTIC. AN EDWARDS PERIMOUNT VALVE WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention