BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3002746 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01464
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A DISSECTION. LESION 1 WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING 2.25 X 32 MM AND 2.25 X 20 MM PROMUS ELEMENT PLUS STENTS. FOLLOWING POST DILATATION WITH NC QUANTUM APEX BALLOON THERE WAS A SMALL GRADE A DISSECTION NOTED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105615 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912420250

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention