BEUDAMED
    FDA Adverse Event Death Summary report: N

    STREAMER GUIDEWIRE

    MDR report key: 2890560 · Received December 20, 2012

    Report

    Report Number
    3006010712-2012-00034
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    August 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K083094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY REVIEW AND THE REVIEW OF THE (B)(6) INVENTORY SAMPLES FROM THE SAME LOT DEMONSTRATE THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A CLINICAL REVIEW OF THE FLUOROSCOPY IMAGES FROM THE PROCEDURE DID NOT INDICATE ANY DEVICE RELATED MALFUNCTION.

    Description of Event or Problem · 1

    A STENOSES ON THE FIRST MARGINAL WAS TREATED BY THE IMPLANTATION OF A BARE METAL STENT (TITAN2). AFTER IMPLANTATION OF THE STENT, A DISSECTION OF THE PROXIMAL FIRST MARGINAL WITH THE STREAMER ES OCCURRED. DISSECTION RESULTED IN MEDICAL COMPLICATIONS AND TO THE DEATH OF THE PT. FURTHER INFO WAS RECEIVED AS FOLLOWS: DURING THE PROCEDURE, A DISSECTION WITH THE FIRST STREAMER OCCURRED IN THE DISTAL PART OF THE FIRST MARGINAL. THEN FURTHER GUIDES WIRES (2 STREAMER AND 4 ASAHI FIELDER XT AND 1 BMW) WAS USED IN ORDER TO CROSS THE DISSECTION. AFTER THAT, HE TRIED TO RESOLVE THE DISSECTION WITH THE INFLATION OF A NON COMPLIANT AND SEMI COMPLIANT BALLOONS TREK (ABBOTT). AFTER INFLATION OF BALLOONS, THE PHYSICIAN DECIDE TO TRANSFER THE PTS IN ANOTHER HOSPITAL TO HAVE AN EMERGENCY SURGERY, BUT THE PT DIED BEFORE HAVING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STREAMER GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 356786 10132858

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death