BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 4882475 · Received July 1, 2015

    Report

    Report Number
    2029214-2015-00734
    Event Type
    Death
    Date Received
    July 1, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS IT WAS IMPLANTED IN THE PATIENT. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT OF PATIENT DEATH AFTER PIPELINE FLEX TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA). TWO PIPELINE FLEX DEVICES WERE IMPLANTED FOR OPTIMAL COVERAGE OF ANEURYSM NECK AND PROXIMAL WALL APPOSITION. THERE WAS NO REPORT OF MAJOR DIFFICULTIES DURING THE PROCEDURE. THE PATIENT RECEIVED DUAL ANTI-PLATELET TREATMENT BUT PRU LEVELS WERE NOT TESTED. AFTER DEPLOYMENT OF DEVICES, A FINAL WHOLE-HEAD ANGIOGRAM WAS PERFORMED AND A CLOT NEAR A PIPELINE FLEX WAS IDENTIFIED. ABCIXIMAB WAS ADMINISTERED; AFTER LOADING DOSE AND DRIP, THE CLOT WAS RESOLVED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS EXTUBATED. APPROXIMATELY ONE HOUR LATER, THE PATIENT CODED IN RECOVERY AND EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE INTRACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425256 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PED-400-14 A054755

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death