BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT

    MDR report key: 3944856 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01412
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN USED TWO RELIANT BALLOONS AS PART OF THE PROCEDURE. BOTH BALLOONS BURST WHILE BALLOONING IN THE SAME AREA OF THE PROXIMAL COMMON ILIAC ARTERY. THE AREA HAD OVERLAPPING STENT GRAFTS, AND THERE WAS NO MOVEMENT OF THE BALLOONS WHILE THE BALLOON WAS INFLATED. NOTHING UNUSUAL IN THE BALLOONING PROCEDURE WAS NOTED. THE FIRST BALLOON WAS INFLATED APPROXIMATELY 4 TIMES, AND THE SECOND BALLOON WAS USED ABOUT TWICE. AFTER THE SECOND BALLOON BURST, THE PROCEDURE WAS COMPLETED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423032 RELIANT CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 0007155059

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR