BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 13518807 · Received February 11, 2022

    Report

    Report Number
    2029214-2022-00208
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    October 21, 2021
    Report Date
    February 11, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LI X-Y, LI C-H, WANG J-W, LIU J-F, LI H, GAO B-L. ENDOVASCULAR MANAGEMENT OF CEREBRAL ANEURYSMS OF THE POSTERIOR CEREBRAL ARTERY. FRONTIERS IN NEUROLOGY. 2021;12:700516. DOI:10.3389/FNEUR.2021.700516. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LI X-Y, LI C-H, WANG J-W, LIU J-F, LI H, GAO B-L. ENDOVASCULAR MANAGEMENT OF CEREBRAL ANEURYSMS OF THE POSTERIOR CEREBRAL ARTERY. FRONTIERS IN NEUROLOGY. 2021;12:700516. DOI:10.3389/FNEUR.2021.700516. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A PIPELINE DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF ENDOVASCULAR EMBOLIZATION OF CEREBRAL ANEURYSMS AT THE P1¿P3 SEGMENTS OF THE POSTERIOR CEREBRAL ARTERY (PCA). SEVENTY-SEVEN PATIENTS WERE TREATED, INCLUDING COILING ALONE IN 10 PATIENTS, STENT-ASSISTED COILING IN 18, PARENT ARTERY OCCLUSION IN 25, AND PIPELINE EMBOLIZATION DEVICE (PED) IN 24. OF THE 77 PATIENTS, 42 WERE MALE AND THE MEAN AGE WAS 53.2 YEARS. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE DEVICE, AND ALL PATIENTS WERE SUCCESSFULLY TREATED ENDOVA SECULARLY. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -DURING THE PERIPROCEDURAL PERIOD, TWO PED PATIENTS EXPERIENCED ACUTE THROMBUS FORMATION. THERE WERE NO SEQUELAE AFTER IMMEDIATE THROMBOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60704 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention