BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEAR VALVE

    MDR report key: 2791976 · Received October 16, 2012

    Report

    Report Number
    2015691-2012-18469
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ISSUES DURING MANUFACTURING THAT COULD BE RELATED TO THE EVENT. NOTE: THE EVENT WAS INADVERTENTLY ALSO CAPTURED AND SUBMITTED UNDER MANUFACTURER REPORT NUMBER 2015691-2012-18479/COMPLAINT NUMBER (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    TWO (2) 26MM SAPIEN VALVES WERE IMPLANTED DURING THIS CASE, HOWEVER, AT THIS TIME IS UNKNOWN WHICH VALVE (SN# (B)(4)) WAS IMPLANTED FIRST. SERIAL # (B)(4)/MFG. DATE. 4/12/2012 - EXP. DATE 3/18/2012 SERIAL # (B)(4)/MFG. DATE. 1/17/2012 - EXP. DATE 11/26/2013. THE DEVICES WERE NOT RETURNED FOR EVALUATION AS THEY WERE NOT EXPLANTED FROM THE PATIENT; HOWEVER, PER REPORT, THERE WAS NO DEVICE MALFUNCTION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR BOTH OF THE VALVES WAS COMPLETED AND THE DEVICES WERE NOTED TO HAVE MET MANUFACTURER'S SPECIFICATIONS PRIOR TO DISTRIBUTION. (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE PATIENT REGISTRY, DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE DECISION WAS MADE TO DEPLOY A SECOND 26MM SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEAR VALVE REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26 59049717

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention