BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 13445907 · Received February 3, 2022

    Report

    Report Number
    2029214-2022-00151
    Event Type
    Death
    Date Received
    February 3, 2022
    Date of Event
    November 2, 2020
    Report Date
    February 3, 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

    REPORTED PATIENT AGE (53 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LUO, B., KANG, H., ZHANG, H., LI, T., LIU, J., SONG, D., ZHAO, Y., GUAN, S., MAIMAITILI, A., WANG, Y., FENG, W., WANG, Y., WAN, J., MAO, G., SHI, H., <(>&<)> YANG, X. (2020). PIPELINE EMBOLIZATION DEVICE FOR INTRACRANIAL ANEURYSMS IN A LARGE CHINESE COHORT: FACTORS RELATED TO ANEURYSM OCCLUSION. THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS, 13, 1756286420967828. HTTPS://DOI.ORG/10.1177/1756286420967828. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE PIPELINE EMBOLIZATION DEVICE (PED) FOR TREATMENT OF INTRACRANIAL ANEURYSMS IN THE CHINESE POPULATION. 1171 PATIENTS WITH 1322 INTRACRANIAL ANEURYSMS TREATED IN 1319 PROCEDURES WERE INCLUDED IN THE STUDY. THE AVERAGE PATIENT AGE WAS 53.9 ± 11.4 YEARS AND THE MAJORITY OF PATIENT'S INCLUDED IN THE STUDY WERE FEMALE (69.4%). 685 ANEURYSMS WERE TREATED WITH PED ONLY AND 637 ANEURYSMS WERE TREATED WITH PED PLUS COILING. 17 PATIENTS WERE NOTED TO HAVE DIED POST-OPERATIVELY. CAUSE OF DEATH WAS NOT NOTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451067 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death