BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 7555140 · Received May 30, 2018

    Report

    Report Number
    2029214-2018-00466
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 30, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    MFE
    PMA / PMN Number
    P030004/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. FOLLOW-UP HAS BEEN SENT FOR THE DEVICE RETURN. ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MDR# 8020889-2018-00056. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DISTAL TIP OF THE MEDTRONIC GUIDEWIRE BROKE OFF AND REMAINED IN THE PATIENT WHEN IT WAS ROTATED ALONG WITH AN MEDTRONIC FLOW-DIRECTED MICROCATHETER. THE MICROCATHETER WAS THEN OBSERVED TO BE PUNCTURED WHEN IT WAS DESCENDED IN THE PATIENT. IT WAS NOTED THAT THERE WAS RESISTANCE FELT IN THE DISTAL SEGMENT OF THE MICROCATHETER. PRIOR TO THE EVENT, THE FLOW-DIRECTED MICROCATHETER AND GUIDEWIRE WERE ADVANCED TO THE ANTERIOR CEREBRAL A3. THEN THE GUIDEWIRE WAS ROTATED CAUSING THE DISTAL TIP TO BREAK OFF FREELY IN THE PATIENT. THE MICROCATHETER WAS THEN LOWERED AND IT WAS NOTICED TO BE PUNCTURED AT THIS POINT. AN ATTEMPT WAS MADE TO REMOVE THE BROKEN GUIDEWIRE PIECE WITH A MEDTRONIC STENT, BUT IT COULD NOT BE CAPTURED. A DECISION WAS MADE TO LEAVE THE BROKEN GUIDEWIRE DISTAL TIP IN THE PATIENT TO PREVENT CAUSING ANY MORE DAMAGE. A NEW MEDTRONIC FLOW-DIRECTED MICROCATHETER AND MEDTRONIC GUIDEWIRE WERE THEN USED TO PROCEED WITH THE LIQUID EMBOLIC INJECTION WITHOUT ANY MORE COMPLICATIONS. THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY. ACCESS WAS BY FEMORAL ARTERY THAT WAS 10MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395458 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 105-5096-000 A479008

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR