BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4416562 · Received January 14, 2015

    Report

    Report Number
    2029214-2015-00047
    Event Type
    Injury
    Date Received
    January 14, 2015
    Report Date
    December 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: NOSSEK E, CHALIF DJ, CHAKRABORTY S, ET AL. MODIFYING FLOW IN THE ICA BIFURCATION: PIPELINE DEPLOYMENT FROM THE SUPRACLINOID ICA EXTENDING INTO THE M1 SEGMENT¿CLINICAL AND ANATOMIC RESULTS. AJNR AM J NEURORADIOL. NOV 2014; 35:2125¿29. THE ARTICLE DESCRIBES ONE CASE OUT OF SEVEN TOTAL, WHERE POST-PED PROCEDURE THERE WAS A FINDING OF AN ASYMPTOMATIC ANGIOGRAPHIC IN-STENT STENOSIS AT THE M1 (MIDDLE CEREBRAL ARTERY) SEGMENT AT 6-MONTH FOLLOW UP ANGIOGRAPHY WITHOUT NEUROLOGIC SEQUELAE. THE ARTICLE FURTHER MENTIONS THAT OUT OF THE TOTAL SEVEN PATIENTS, CLINICALLY, ALL PATIENTS WERE STABLE IN THE IMMEDIATE POST-PROCEDURAL PERIOD AND ALL HAD NO NEW NEUROLOGIC DEFICITS. ALL PATIENTS MAINTAINED THEIR BASELINE CLINICAL STATUS. THERE WERE NO RADIOGRAPHIC SIGNS OF ISCHEMIA. ONE PATIENT HAS ASYMPTOMATIC ANGIOGRAPHIC IN-STENT STENOSIS OF THE M1 SEGMENT AT 6-MONTH POST-PED PROCEDURE. PATIENT OUTCOME WAS STABLE IMMEDIATELY POST-PROCEDURE AND HAD NO NEW NEUROLOGICAL DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31655 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability