BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 9235911 · Received October 24, 2019

    Report

    Report Number
    2029214-2019-01071
    Event Type
    Death
    Date Received
    October 24, 2019
    Date of Event
    January 23, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. THE DEVICE WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2019-01072. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRIMIANI, C. T., REN, Z., KAN, P., HANEL, R., PEREIRA, V. M., LUI, W. M., ¿ MOKIN, M. (2019). A2, M2, P2 ANEURYSMS AND BEYOND: RESULTS OF TREATMENT WITH PIPELINE EMBOLIZATION DEVICE IN 65 PATIENTS. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 11(9), 903¿907. DOI: 10.11 36/NEURINTSURG-2018-014631 MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF PATIENT COMPLICATIONS AFTER PIPELINE PLACEMENT. THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE THE RESULTS OF PIPELINE TREATMENT OF DISTAL INTRACRANIAL ANEURYSMS. THE AUTHORS REVIEWED THE RESULTS OF 65 PATIENTS WITH DISTAL ANEURYSMS TREATED WITH PIPELINE. OF THE 65 PATIENTS, THE MEAN AGE WAS 54.7 YEARS; 42 OF THE PATIENTS WERE FEMALE. THE ARTICLE NOTES THE FOLLOWING EVENTS: - ONE PATIENT UNDERWENT PIPELINE PLACEMENT IN THE TREATMENT OF A SACCULAR, M2 ANEURYSM. THE EXPERIENCED IPSILATERAL HEMORRHAGE WITHIN THE FIRST 24 HOURS POST-PROCEDURE. THE PATIENT UNDERWENT DECOMPRESSIVE CRANIECTOMY AND HEMATOMA EVACUATION. THE PATIENT PASSED AWAY WITHIN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027734 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death