BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 2200879 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03166
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-03154. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY ANGIOPLASTY TREATMENT PROCEDURE A VESSEL DISSECTION OCCURRED. THE SUB TOTALLY OCCLUDED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND NON TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PREDILATED WITH A 2.00X20MM APEX BALLOON CATHETER INFLATED TWICE TO A MAXIMUM OF 12 ATMS. A SMALL DISSECTION MAY HAVE OCCURRED, BUT COULD NOT BE CONFIRMED VIA ANGIOGRAPHY. A 3.00X24MM ION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE LCX AND WOULD NOT CROSS THE LESION. UPON REMOVAL IT WAS NOTED THAT STENT STRUTS WERE LIFTED OFF OF THE BALLOON. THE LESION WAS AGAIN PREDILATED WITH AN UNSPECIFIED BALLOON AND 3.00X38MM ION SDS WAS ADVANCED TO THE LESION AND DEPLOYED. TIMI 3 FLOW WAS ESTABLISHED AND THE 3.00X38MM ION SUCCESSFULLY TREATED ANY DISSECTION THAT MAY HAVE OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895920200 13670491

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention