BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 2041950 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01326
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS LISTED AS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MFR REPORT #: 2134265-2011-01325. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 2.5X14MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE-DILATION USING TWO 2.0X15MM APEX BALLOONS AND THE PLACEMENT OF A (B)(4) STUDY STENT. A PERFORATION OF THE LAD WITH BLOOD EFFUSION WAS NOTED AFTER THE DEPLOYMENT OF THE STUDY STENT WHICH WAS TREATED WITH AN ADDITIONAL (B)(4) STUDY STENT AND A NON BSC GRAFTING STENT. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY. IN ADDITION, A NON-TARGET LESION LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH WAS ALSO TREATED AT THE INDEX PROCEDURE WHICH WAS TREATED WITH A 2.5X12MM PROMUS ELEMENT. THE PATIENT WAS DISCHARGED 3 DAYS POST THE INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915200 13937391

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4) STUDY STENT| 2.0X15MM APEX BALLOON