BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 1934828 · Received December 21, 2010

    Report

    Report Number
    2134265-2010-05441
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING A STENTING TREATMENT PROCEDURE A DISSECTION OCCURRED. THE 90 % STENOSED, 3.00X10MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A NON BSC GUIDE CATHETER WAS ADVANCED TO THE LESION AND WAS DEEP SEATED. A 2.50X12MM APEX BALLOON CATHETER WAS THEN ADVANCED TO THE LESION FOR PREDILATION AND IT WAS NOTED THAT THE PREDILATION WAS "UNREMARKABLE". A 2.5X18MM PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA BUT WAS UNABLE TO CROSS THE LESION AND ACCESS TO THE LESION WAS LOST. WHEN ACCESS WAS REGAINED AND DYE WAS INJECTED A "HIGH" GRADE DISSECTION WAS NOTED THAT SPIRALED INTO THE AORTA. THE RCA CLOSED DOWN DUE TO THE DISSECTION AND THE PATIENT WENT TO SURGERY AND CABG WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895912250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F JR 4 CORDIS GUIDE CATHETER| TERUMO RUNWAY GUIDE WIRE