BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2872878 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18843
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIO-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. DESPITE EXHAUSTIVE ATTEMPTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. CONSEQUENTLY, NONE OF THE ABOVE POTENTIAL CAUSES OF VALVE STENOSIS CAN BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF AORTIC STENOSIS ALMOST FIVE YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization