BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4361749 · Received December 24, 2014

    Report

    Report Number
    2029214-2014-00752
    Event Type
    Injury
    Date Received
    December 24, 2014
    Report Date
    December 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: PHILLIPS TJ, WENDEROTH JD, PHATOUROS CC, ET AL. SAFETY OF THE PIPELINE EMBOLIZATION DEVICE IN TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS. AJNR AM J NEURORADIOL 33:1225¿31. THIRTY-TWO POSTERIOR CIRCULATION ANEURYSMS WERE TREATED IN 32 PATIENTS AND NO DEATHS OR POOR NEUROLOGICAL OUTCOMES OCCURRED. PERFORATOR TERRITORY INFARCTIONS OCCURRED IN THREE OF THE 21 PATIENTS WITH BASILAR ARTERY ANEURYSMS, AND IN ALL THREE, A SINGLE PIPELINE WAS USED. TWO ASYMPTOMATIC INTRACRANIAL HEMATOMAS WERE RECORDED. NO ANEURYSM RUPTURE OR PIPELINE THROMBOSIS WAS ENCOUNTERED. THE OVERALL RATE OF PERMANENT NEUROLOGIC COMPLICATIONS WAS 9.4% (3/32); ALL 3 PATIENTS HAD VERY MILD RESIDUAL SYMPTOMS AND A GOOD CLINICAL OUTCOME. ANEURYSM OCCLUSION WAS DEMONSTRATED IN 85% OF PATIENTS WITH 6 MONTHS OF FOLLOW-UP AND 96% OF PATIENTS WITH 1 YEAR OF FOLLOW-UP. PATIENT #20: THE PATIENT PRESENTED WITH BASILAR TIP-POSTERIOR CEREBRAL ARTERY ANEURYSM AND SUFFERED AN IN-CONSTRUCT STENOSIS WITHOUT FLOW LIMITATION DEMONSTRATED ON 6-MONTH DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) FOLLOWING PIPELINE IMPLANTATION. ON 12-MONTH DSA, THE STENOSIS HAD RESOLVED. THE PATIENT'S MRS SCORE WAS 0. THIS INFORMATION WAS RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2014-00785 / 2029214-2014-00753 / 2029214-2014-00754 / 2029214-2014-00756 / 2029214-2014-00757 / 2029214-2014-00755.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849483 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other