BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4889445 · Received July 2, 2015

    Report

    Report Number
    2029214-2015-00763
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 23, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. OFF LABEL USE IN THE USA: PER PIPELINE FLEX INSTRUCTION FOR USE: THE PIPELINE FLEX EMBOLIZATION DEVICE 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.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT THROUGH LITERATURE THAT A PATIENT DIED THREE DAYS POST PIPELINE FLEX PROCEDURE. THE PATIENT PRESENTED WITH A LONG-TERM HEADACHE. MAGNETIC RESONANCE IMAGING SHOWING A 40 MM LEFT MIDDLE CEREBRAL ARTERY (MCA) PARTIALLY THROMBOSED ANEURYSM. LEFT INTERNAL CAROTID ARTERY (ICA) PRE TREATMENT IMAGING SHOWED A SLOW FLOW DISTALLY FROM THE ANEURYSM. POST TREATMENT LEFT ICA IMAGING SHOWED A SIGNIFICANT CHANGE IN THE MCA FLOW DISTALLY FROM THE ANEURYSM. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AFTER THE PROCEDURE. THE PIPELINE EMBOLIZATION DEVICE AND CONTRAST MATERIAL INSIDE THE ANEURYSM WITH NO BLEEDING ARE OBSERVED. TWO DAYS AFTER PROCEDURE, CT DEMONSTRATING A LARGE INTRAPARENCHYMAL HEMATOMA FAR FROM THE ANEURYSM. THE HEMATOMA WAS PROMPTLY DRAINED; HOWEVER, THE PATIENT DIED IN THE THIRD DAY POST PROCEDURE. THE AUTHORS STATED THE CAUSE OF THE INTRAPARENCHYMAL HEMORRHAGE IN THIS PATIENT WAS PROBABLY HYPERPERFUSION RELATED TO A SIGNIFICANT INCREASE IN THE MIDDLE CEREBRAL ARTERY (MCA) FLOW DISTALLY FROM THE ANEURYSM IMMEDIATELY POST PROCEDURE. THE AUTHORS PRESENT THE RESULTS OF TREATMENT OF INTRACRANIAL ANEURYSMS WITH FLOW DIVERTER STENTS IN A SINGLE CENTER. RETROSPECTIVE REVIEW OF 77 PATIENTS WITH 87 ANEURYSMS TREATED USING TWO DIFFERENT TYPES OF FLOW DIVERTER STENT, THE PIPELINE EMBOLIZATION DEVICE AND SILK STENT, BETWEEN (B)(6) 2010 AND (B)(6) 2013 IN AN INTERVENTIONAL NEURORADIOLOGY CENTER. CITATION: GIACOMINI L,PISKE RL, BACCIN CE, ET AL. NEUROVASCULAR RECONSTRUCTION WITH FLOW DIVERTER STENTS FOR THE TREATMENT OF 87 INTRACRANIAL ANEURYSMS: CLINICAL RESULTS. INTERV NEURORADIOL. 2015 JUN;21(3):292-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430455 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PIPELINE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death