BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 3201047 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04537
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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

    SAME CASE AS MFR ID # 2134265-2013-04526, 2134265-2013-04536, 2134265-2013-04737, 2134265-2013-04538. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO ION STENTS WERE PLACED IN THE LAD ONE MID LESION AND ONE IN THE PROXIMAL LESION. THE DAYS AFTER THE INITIAL PROCEDURE THE PATIENT PRESENTED AGAIN WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. IN-STENT THROMBOSIS WAS ALSO NOTED IN THE PROXIMAL END OF STENT IMPLANTED STENT PLACED IN THE PROXIMAL LAD. THE LAD WAS WIRED AND MECHANICAL THROMBECTOMY WAS PERFORMED. THE LESION WAS DILATED WITH A 2.5X20MM APEX, 3.0X20MM NC QUANTUM, AND A 3.5X12MM NC QUANTUM BALLOONS. IVUS WAS PERFORMED AND A DISSECTION WAS NOTED ON THE DISTAL END OF THE IMPLANTED STENT. THE DISSECTION WAS COVERED WITH A 2.25X16MM ION STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303169 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention