BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE

    MDR report key: 9843413 · Received March 17, 2020

    Report

    Report Number
    2029214-2020-00244
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    October 1, 2015
    Report Date
    March 17, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    LV X, JIANG C, WU Z, JIANG W, WANG G. COMPLEX CEREBRAL ANEURYSMS: INTRA-LUMINAL RECONSTRUCTION USING PIPELINE FLOW-DIVERTING STENT AND THE OBLITERATION MECHANISM. THE NEURORADIOLOGY JOURNAL. DECEMBER 2019:1971400919894879. DOI:10.1177/1971400919894879. MEDTRONIC RECEIVED A REPORT THROUGH LITERATURE TO DOCUMENT THE CLINICAL AND ANGIOGRAPHIC OUTCOMES IN 80 PATIENTS WHO WERE TREATED WITH THE PIPELINE FLOW-DIVERTING STENT. FORTY-FIVE PATIENTS WERE WOMEN AND 35 WERE MEN, WITH A MEAN AGE OF 52 YEARS. THE STUDY TOOK PLACE BETWEEN OCTOBER 2015 AND OCTOBER 2019, 80 PATIENTS WITH 90 COMPLEX BLOOD BLISTER¿LIKE, AND RECURRENT SIDE-WALL CEREBRAL ANEURYSMS TREATED WITH THE PIPELINE WERE REVIEWED. FORTY-ONE ANEURYSMS WERE LARGE OR GIANT, 41 WERE SMALL, FOUR WERE RECURRENT SIDE-WALL ANEURYSMS, AND FOUR WERE BLOOD BLISTER¿LIKE ANEURYSMS. IN SEVEN PATIENTS, A SECOND PFS WAS NECESSARY TO COVER THE ANEURYSM NECK. AMONG THEM, COILS WERE PLACED IN ADDITION TO THE PFS IN 31 ANEURYSMS. 82 OF 83 ANEURYSMS WERE OCCLUDED FOR A TOTAL OCCLUSION RATE OF 98.8% THERE WAS NO PATIENT RELATED MORBIDITY. MORTALITY OCCURRED IN ONE PATIENT DUE TO THROMBOLYSIS FROM THROMBUS FORMATION IN THE LEFT ICA, RESULTING IN AN IPSILETARAL REMOTE INTRAPARENCHYMAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306186 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR