BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 7452653 · Received April 23, 2018

    Report

    Report Number
    2029214-2018-00336
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    September 14, 2017
    Report Date
    April 23, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADEEB, N., MOORE, J., WIRTZ, M., GRIESSENAUER, C., FOREMAN, P., SHALLWANI, H., . . . OGILVY, C. (2017). PREDICTORS OF INCOMPLETE OCC LUSION FOLLOWING PIPELINE EMBOLIZATION OF INTRACRANIAL ANEURYSMS: IS IT LESS EFFECTIVE IN OLDER PATIENTS? AMERICAN JOURNAL OF NEURORADIOLOGY, 38(12), 2295-2300. DOI:10.3174/AJNR.A5375 THE PIPELINE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED IN THE PATIENTS. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2018-00336 2029214-2018-00337. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF PATIENT COMPLICATIONS AFTER PIPELINE IMPLANTATION. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS PREDICTORS OF INCOMPLETE OCCLUSION AFTER PIPELINE EMBOLIZATION DEVICE (PED) TREATMENT. THE AUTHORS RETROSPECTIVELY REVIEWED 380 ANEURYSMS TREATED BY 329 PED PROCEDURES IN 329 PATIENTS. OF THE 329 PATIENTS, 272 WERE FEMALE AND 57 WERE MALE; THE MEDIAN AGE WAS 58 YEARS. THE ARTICLE NOTED THE FOLLOWING OUTCOMES AFTER PED PLACEMENT: - 24 PATIENTS UNDERWENT ENDOVASCULAR RETREATMENT - 31 PATIENTS EXPERIENCED THROMBOEMBOLIC COMPLICATIONS, 17 OF WHICH WERE SYMPTOMATIC - 11 PATIENTS EXPERIENCED HEMORRHAGIC COMPLICATIONS, 6 OF WHICH WERE SYMPTOMATIC

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293590 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R