BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1221531 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04218
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE LESION WAS 99% STENOSED BIFURCATIONS AND WAS LOCATED IN A MODERATELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND 1ST DIAGONAL BRANCH. A APEX BALLOON WAS PREDILATED IN THE 1ST DIAGONAL BRANCH THEN PREDILATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A NON BSC STENT WAS DEPLOYED IN THE 1ST DIAGONAL LESION AND IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X15MM APEX MONORAIL BALLOON ATTEMPTED TO CROSS IN THE 1ST DIAGONAL THROUGH A STENT STRUT, HOWEVER, IT WAS DIFFICULT TO CROSS THERE. WHEN THE BALLOON CROSSED THROUGH THE STENT STRUT, ON THE FIRST INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED INTACT. A 2.25MM APEX BALLOON WAS ABLE TO CROSS THE STENT STRUT AND DILATE. THE PATIENT STATUS IS "NO PROBLEM" WITH NO COMPLICATIONS REPORTED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X15 MM 119577546

    Patients

    Seq Age Sex Outcome Treatment
    1 18+ GC: 7F HEARTRAIL JL4.0| GW: RUNTHROUGH| STENT: CYPHER 2.75MM