BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5128589 · Received October 5, 2015

    Report

    Report Number
    2029214-2015-05027
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAME EVENT AS REPORTED IN MDR 2029214-2015-05026. THIS MDR REPORTS THE SECOND PIPELINE USED IN THIS EVENT. THE PIPELINE DEVICE IN THIS REPORT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED SUCCESSFULLY IN THE PATIENT. THE EVENT CAUSE COULD NOT BE DETERMINED FROM THE REPORTED INFORMATION, HOWEVER EVIDENCE EXISTS TO SUPPORT THAT THE MOST LIKELY CONTRIBUTING FACTORS ARE THE PATIENT'S VESSEL TORTUOUSITY AND THAT THE PHYSICIAN DID NOT ROTATE THE DELIVERY WIRE ENOUGH TO DETACH THE PIPELINE FROM THE CAPTURE COIL. IT WAS REPORTED THAT THE PATIENT'S VESSEL WAS REPORTED TO BE SEVERELY TORTUOUS. PER PIPELINE INSTRUCTION FOR USE: "DO NOT USE IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES THE ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT, DUE TO CONDITIONS SUCH AS SEVERE INTRACRANIAL VESSEL TORTUOSITY OR STENOSIS." ADDITIONALLY, THE PHYSICIAN ATTEMPTED TO ROTATE THE DELIVERY WIRE THREE TIMES BEFORE DECIDED TO REMOVE PIPELINE. HOWEVER, DURING THE ATTEMPT TO REMOVE THE PIPELINE, THE PIPELINE OPEN AS INTENDED. PER PIPELINE INSTRUCTION FOR USE, "DETACHMENT CAN BE FACILITATED BY SLOWLY ROTATING THE DELIVERY WIRE IN THE CLOCKWISE DIRECTION AND/OR MANIPULATING THE MICRO CATHETER BY LOCKING DOWN THE DELIVERY WIRE AND MOVING BOTH AS A SYSTEM. NEVER ROTATE THE DELIVERY WIRE MORE THAN 10 FULL TURNS. IF PED DOES NOT OPEN AFTER 10 TURNS, REMOVE THE ENTIRE SYSTEM (MICRO CATHETER AND PED DELIVERY SYSTEM TOGETHER). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT THAT TWO PIPELINE DEVICES WERE STUCK IN CAPTURE COIL DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, LARGE FUSIFORM ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE VESSEL WAS SEVERELY TORTUOUS. THE MICROCATHETER WAS NAVIGATED TO THE MIDDLE CEREBRAL ARTERY (MCA) AND THE FIRST PIPELINE WAS TRACKED THROUGH WITHOUT ANY ISSUES. THE MICROCATHETER WAS PULLED BACK AND THE PIPELINE WAS PUSHED FORWARD UNTIL IT FORMED A GOOD CIGAR SHAPE. THE PHYSICIANS NOTICED THAT THE PIPELINE DID NOT SEPARATE FROM THE CAPTURE COIL. THE MICROCATHETER AND GUIDE CATHETER WERE ADJUSTED, PUSHING FORWARD AND ROTATING THE PIPELINE DELIVERY WIRE, BUT THESE ATTEMPTS WERE NOT EFFECTIVE. IT IS NOT KNOWN HOW MANY TIMES THE DELIVERY WIRE WAS ROTATED. THE PHYSICIANS DECIDED TO REMOVE THE ENTIRE SYSTEM. THE PHYSICIANS LOCKED DOWN THE DISTAL END AND PULLED THE MICROCATHETER BACK TOGETHER WITH THE PIPELINE. A NEW MICROCATHETER WAS PLACED IN POSITION AND A NEW PIPELINE WAS TRACKED WITHOUT ANY ISSUES. A GOOD CIGAR SHAPE WAS FORMED AT THE M1 MCA. THE MICROCATHETER WAS PULLED BACK AND THE PIPELINE DELIVERY SYSTEM WAS PUSHED FORWARD, BUT THE TIP WOULD NOT OPEN. THE PHYSICIANS PUSHED THE DELIVERY SYSTEM FORWARD AND ROTATED THREE TIMES, BUT THESE ATTEMPTS WERE UNSUCCESSFUL IN OPENING THE DEVICE. THE PHYSICIANS DECIDED TO ABORT THE SURGERY. THE DISTAL END OF THE SYSTEM WAS LOCKED DOWN AND THE PIPELINE WAS PULLED BACK, AT WHICH TIME THE PIPELINE OPENED. THE PHYSICIANS CONFIRMED THAT THE POSITION WAS APPROPRIATE AND CONTINUED TO DELIVER THE DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT AND IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658899 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-71450-25 9956715

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR