BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 4931966 · Received July 22, 2015

    Report

    Report Number
    2029214-2015-00802
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    IRVINE
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER WAS REVIEWED AND NO DISCREPANCIES THAT MIGHT HAVE CAUSED THE REPORTED EVENT WERE NOTED. THE MICROCATHETER, PUSHWIRE AND PIPELINE FLEX WERE RETURNED FOR EVALUATION. THE PUSHWIRE WAS FOUND INSIDE THE MICROCATHETER. FOR FURTHER INVESTIGATION, THE PUSHWIRE AND PIPELINE FLEX WERE REMOVED FROM THE MICROCATHETER LUMEN. THE TIP COIL APPEARED TO BE DAMAGED. THE DISTAL HYPOTUBE APPEARED TO BE SLIGHTLY STRETCHED. THE PUSHWIRE APPEARED TO BE BENT AT A SEGMENT NEAR THE DISTAL TIP COIL. THE DISTAL END OF THE PIPELINE FLEX WAS NOT OPENED DUE TO DAMAGED BRAID. THE PROXIMAL END OF THE PIPELINE FLEX WAS FOUND OPENED WITH DAMAGED BRAID. THE MICROCATHETER APPEARED TO BE ACCORDIONED AT A SEGMENT ON THE DISTAL END. AN IN-HOUSE MANDREL WAS INSERTED THROUGH THE MICROCATHETER TIP AND HUB AND IT GOT STUCK AT THE DAMAGED LOCATIONS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON EVALUATION OF RETURNED DEVICES, THE CUSTOMER¿S REPORT OF PIPELINE FLEX FAILURE TO OPEN DISTALLY WAS CONFIRMED. IT IS POSSIBLE THAT THE TORTUOUS ANATOMY AND THE DAMAGE TO THE BRAID MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE PUSHWIRE AND MICROCATHETER WERE ALSO DAMAGED. THE CAUSE FOR DAMAGE COULD NOT BE DETERMINED. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. PER PIPELINE FLEX 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. THIS EVENT IS ALSO REPORTED IN MDR # 2029214-2015-00803 AND 2029214-2015-00804. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT THAT DURING A PROCEDURE, TWO PIPELINE FLEX DEVICES DID NOT OPEN DISTALLY AND A MARKSMAN BROKE WITHIN THE GUIDE CATHETER. THE ANEURYSM WAS PREVIOUSLY CLIPPED, UNRUPTURED, SACCULAR, LOCATED IN THE LEFT, OPHTHALMIC INTERNAL CAROTID ARTERY (ICA). PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. THE TWO PIPELINE FLEX DEVICES WERE ADVANCED EASILY WITHOUT ISSUE. DURING DELIVERY, BOTH PIPELINE FLEX DEVICES (MDR #2029214-2015-00802 AND #2029214-2015-00803) WOULD NOT OPEN DISTALLY. THE DEVICES WERE RESHEATHED AND RE-DEPLOYED TWO TIMES EACH IN AN EFFORT TO RELAX THE BRAID. THESE ATTEMPTS WERE UNSUCCESSFUL. THE PIPELINE FLEX DEVICES WERE RE-SHEATHED AND REMOVED BY GRASPING THE PIPELINE FLEX DELIVERY WIRE AND MICROCATHETER TOGETHER. A PIPELINE CLASSIC WAS THEN IMPLANTED SUCCESSFULLY. DURING PUSHWIRE REMOVAL, THE DISTAL CAPTURE COIL BECAME TRAPPED IN THE MID-SECTION OF THE MICROCATHETER. WHEN APPLYING ADDITIONAL FORCE TO REMOVE THE MICROCATHETER, THE MIDDLE SEGMENT OF THE MARKSMAN MICROCATHETER FRACTURED WITHIN THE GUIDE CATHETER (MDR #2029214-2015-00804). THE FRACTURED MICROCATHETER PIECES WERE STILL IN THE GUIDE CATHETER AND WERE REMOVED WITH THE GUIDE CATHETER. ANGIOGRAPHIC RESULT POST-PROCEDURE WAS VERY SLIGHT CONTRAST STAGNATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476217 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT IRVINE PED-500-14 A069820

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR