BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4650391 · Received April 1, 2015

    Report

    Report Number
    2029214-2015-00334
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. REQUESTS HAVE BEEN MADE FOR THE REASON OF NON-RETURN; HOWEVER, NO CORRESPONDENCE REGARDING THE DEVICE HAS BEEN RECEIVED. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. THE MICROCATHETER, PUSHWIRE AND PIPELINE WERE RETURNED FOR EVALUATION. THE PUSHWIRE WAS FOUND OUTSIDE CATHETER. THE PIPELINE WAS NOT ATTACHED TO THE PUSHWIRE. THE CAPTURE COIL APPEARED TO BE STRETCHED. THE CATHETER BODY APPEARED TO BE FLATTENED AT TWO DIFFERENT SITES CLOSE TO THE DISTAL TIP. AN IN-HOUSE MANDREL WAS INSERTED THROUGH THE CATHETER TIP AND HUB AND IT GOT STUCK AT THE DAMAGED LOCATIONS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ABOVE FINDINGS, THE CUSTOMER'S REPORT COULD NOT BE CONFIRMED. THE CAUSE FOR THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE PIPELINE WAS RETURNED FULLY OPENED WITH DAMAGED BRAID. IT IS POSSIBLE THAT THE TORTUOUS ANATOMY AND THE DAMAGE TO THE BRAID AND PUSHWIRE MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE SUBSEQUENTLY CAUSING FAILURE TO OPEN. HOWEVER, THE CAUSE FOR DAMAGES COULD NOT BE DETERMINED. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. PER PIPELINE FLEX IFU (INSTRUCTIONS 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.

    Description of Event or Problem · 1

    TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 6MM X 4MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). MEDTRONIC (COVIDIEN) RECEIVED INFORMATION REGARDING AN INCIDENT INVOLVING ONE OF ITS DEVICES. DURING THE PROCEDURE, IT WAS REPORTED THE PROXIMAL END OF THE PIPELINE WOULD NOT OPEN. IT WAS REPORTED THE PROXIMAL ANATOMY WAS TORTUOUS AND THERE WERE SEGMENTS OF THE ACCESSED VESSEL THAT WERE STENOTIC. FOR THIS REASON, THE PHYSICIAN WANTED TO CONSTRUCT A TRI-AXIAL SUPPORT SYSTEM WITH A DAC .044 IN PLACE OF THE NAVIEN .058. THE DAC .044 COULD HAVE OVALIZED DIMINISHING THE 1-TO-1 PUSH/PULL OF THE PIPELINE DEPLOYMENT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY A 4.50 X 16 MM PIPELINE DEVICE AT THE INTENDED LOCATION, THE PROXIMAL END DID NOT OPEN UNIFORMLY. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE BY PULLING BACK THE DELIVERY CORE WIRE UNTIL THE PIPELINE WAS SECURED AT THE TIP OF THE MICRO CATHETER AND THEN REMOVED THE ENTIRE SYSTEM. SECOND PIPELINE DEVICE (4.5X14) WAS IMPLANTED AND THE PATIENT IS DOING FINE. ANGIOGRAPHIC RESULT IMMEDIATELY POST PROCEDURE SHOWED ECLIPSE BLOOD FLOW. THE PATIENT RECEIVED DUAL ANTIPLATELET THERAPY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215446 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77450-16 9979351

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR SECOND PIPELINE DEVICE (4.5X14)