BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 9836772 · Received March 16, 2020

    Report

    Report Number
    2029214-2020-00234
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    May 1, 2015
    Report Date
    March 16, 2020
    Manufacturer
    MEDTRONIC
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OGUZ S, TABAKCI ÖN, UYSAL E, BULUT E, DINÇ H. PIPELINE FLEX EMBOLIZATION DEVICE (PED FLEX) FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS: PERIPROCEDURAL OUTCOMES AND FIRST-YEAR ANGIOGRAPHIC RESULTS. TURKISH JOURNAL OF MEDICAL SCIENCES. 2019;49(6):1640. HTTP://SEARCH .EBSCOHOST.COM/LOGIN.ASPX?DIRECT=TRUE<(>&<)>DB=EDB<(>&<)>AN=140821945<(>&<)>SITE=EDS-LIVE. ACCESSED MARCH 16, 2020. MEDTRONIC RECEIVED A REPORT REGARDING A STUDY TO EVALUATE THE EFFICACY OF THE PIPELINE FLEX DEVICE. THE AUTHORS REVIEWED 49 PATIENTS WITH A MEAN AGE OF 52 YEARS, 63% FEMALE. THE AVERAGE ANEURYSM DIAMETER WAS 8MM. INTRAPROCEDURAL OR PERIPROCEDURAL THROMBOEMBOLIC EVENTS OCCURRED IN FOUR PATIENTS. ALL THESE PRESENTED WITH MINOR NEUROLOGICAL DEFICITS, AND THERE WERE NO CLINICAL DEFICITS AT DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299782 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR