BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 6190834 · Received December 20, 2016

    Report

    Report Number
    2134265-2016-11910
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: 1934. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A TAVI PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS AND IT WAS DECIDED TO PERFORM A TAVI PROCEDURE. A NON-BSC VALVE WAS ADVANCED THROUGH THE TORTUOUS AND CALCIFIED AORTIC ARCH. WHILE ADVANCING THE VALVE A BLOCKAGE WAS ENCOUNTERED WITH THE AMPLATZ SUPER STIFF GUIDE WIRE AS THERE WAS AN ABRASION OF THE COATING ON THE WIRE. THE ABRASION OF THE COATING LOCKED THE MOBILITY OF THE AMPLATZ SUPER STIFF GUIDE WIRE IN THE LUMEN OF THE CARRIER SYSTEM OF THE NON-BSC VALVE. THE NON-BSC VALVE COULD NOT BE ADVANCED FURTHER AND WAS PULLED BACK INTO THE ¿BAR¿ WHERE AN ILIAC PERFORATION OCCURRED. A NEW GUIDE WIRE AND NON-BSC VALVE WERE THEN ADVANCED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. A FEW HOURS LATER THE PATIENT EXPERIENCED ABRUPT ELECTROMECHANICAL DECOUPLING AND RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL. THE AUTOPSY REPORT SHOWED THAT THE CAUSE OF DEATH IS DUE TO A PERFORATION IN THE AREA OF THE IMPLANTED NON-BSC VALVE WHICH APPEARS IN THE HEART SAC WITH ACUTE PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839979 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK531

    Patients

    Seq Age Sex Outcome Treatment
    1 Death