BEUDAMED
    FDA Adverse Event Death Summary report: N

    APEX¿ PUSH

    MDR report key: 2946364 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00436
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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

    SAME CASE MDR ID: 2134265-2013-00434. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THE PATIENT EXPIRED. THE 95% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL (OM) ARTERY. THE LESION WAS PREDILATED WITH A 2.00X12MM APEX BALLOON CATHETER TO 12 ATMOSPHERES. A 2.50X16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED BUT COULD NOT CROSS THE LESION, THE SDS WAS GOING TO BE REMOVED WHEN IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WAS FLARED. THE SDS, GUIDE CATHETER AND NON-BSC GUIDE WIRE WERE ALL REMOVED. A NON-BSC GUIDE CATHETER WAS THEN ADVANCED AND ABLE TO REGAIN ACCESS TO THE OM VIA THE NATIVE LEFT MAIN CORONARY ARTERY, THE SAME NON-BSC GUIDE WIRE WAS THEN ADVANCED TO THE OM. THE SAME 2.00X12MM APEX BALLOON CATHETER WAS THEN ADVANCED BUT COULD NOT CROSS THE LESION. A 1.20X12MM NON-BSC BALLOON CATHETER WAS THEN ADVANCED AND WAS ALSO UNABLE TO CROSS THE LESION. A 1.50X12MM APEX PUSH BALLOON CATHETER WAS THEN ADVANCED AND WAS ABLE TO CROSS HALF OF THE LESION. THE 1.50X12MM APEX PUSH BALLOON WAS INFLATED. A 1.20XMM NON-BSC BALLOON WAS THEN ADVANCED TO THE LESION AND AT THIS TIME THE PATIENT CODED. ALL OF THE DEVICES WERE REMOVED FROM THE PATIENT AND CHEST COMPRESSIONS AND BALLOON PUMP WERE USED TO STABILIZE THE PATIENT, HOWEVER THE PATIENT EXPIRED. IN THE OPINION OF THE PHYSICIAN, THE PATIENT'S SMALL MARGINAL BRANCH WAS SUPPORTING THE HEART AND WHEN INTERVENTION OF THE BRANCH WAS UNSUCCESSFUL THE PATIENT COULD NOT RECOVER. IT IS THE OPINION OF THE PHYSICIAN THAT THE BSC DEVICES WERE NOT RELATED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50835 APEX¿ PUSH CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896112150

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 2.00X12MM APEX BALLOON CATHETER| AL1 LAUNCHER GUIDE CATHETER| 1.20X12MM TREK BALLOON CATHETER| 190CM WHISPER GUIDE WIRE| 2.50X16MM PROMUS ELEMENT PLUS SDS| 6F LCB LAUNCHER GUIDE CATHETER