BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5025162 · Received August 24, 2015

    Report

    Report Number
    2029214-2015-00903
    Event Type
    Death
    Date Received
    August 24, 2015
    Date of Event
    June 18, 2015
    Report Date
    August 4, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://INE.SAGEPUB.COM/CONTENT/21/4/434. LONG OFF LABEL USE: TREATMENT OF VERTEBROBASILAR FUSIFORM (VBF) ANEURYSMS. THE PIPELINE¿ EMBOLIZATION DEVICE (PED) IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. OTHER SERIOUS ADVERSE EVENTS FROM THE SAME ARTICLE WAS REPORTED IN THE FOLLOWING MDRS: CASE#1 (MDR# 2029214-2015-00904); CASE #2 (MDR# 2029214-2015-00905); CASE#3 (MDR# 2029214-2015-00907); CASE #4 (MDR# 2029214-2015-00903).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT A PATIENT EXPERIENCED ISCHEMIA POST PIPELINE PROCEDURE. THE PATIENT WAS TREATED FOR A GIANT ANEURYSM LOCATED IN HOLOBASILAR ARTERY AND BILATERAL VERTEBRAL ARTERIES. ONE PED DEVICE, 3 INTRAVASCULAR STENTS, AND COILS WERE USED IN ATTEMPT TO SACRIFICE OF THE VERTEBRAL ARTERY BUT IMMEDIATE ISCHEMIC INSULT PREVENTED THE AUTHORS FROM OBSERVING THE RISK OF LONG TERM RECURRENCE. IN THIS PAPER, THE AUTHORS RETROSPECTIVELY REVIEWED FOUR PATIENTS TREATED WITH PEDS FOR VERTEBROBASILAR FUSIFORM ANEURYSMS BETWEEN (B)(6) 2012 TO (B)(6) 2014. CITATION: AHMED O, STOREY C, KALAKOTI P, ET AL. TREATMENT OF VERTEBROBASILAR FUSIFORM ANEURYSMS WITH PIPELINE EMBOLIZATION DEVICE. INTERVENTIONAL NEURORADIOLOGY 2015, VOL. 21(4) 434-440.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558430 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-71450-35

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death