BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 9234184 · Received October 24, 2019

    Report

    Report Number
    2029214-2019-01069
    Event Type
    Death
    Date Received
    October 24, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 24, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE RELATED REGULATORY REPORT 2029214-2019-01068. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    GRIESSENAUER CJ, THOMAS AJ, ENRIQUEZ-MARULANDA A, ET AL. COMPARISON OF PIPELINE EMBOLIZATION DEVICE AND FLOW RE-DIRECTION ENDOLUMINAL DEVICE FLOW DIVERTERS FOR INTERNAL CAROTID ARTERY ANEURYSMS: A PROPENSITY SCORE-MATCHED COHORT STUDY. NEUROSURGERY. 2019; 85 (2): E249-E255. DOI: 10.1093/NEUROS/NYY572. MEDTRONIC RECEIVED A REPORT FROM A CLINICAL STUDY THROUGH A LITERATURE ARTICLE TO PERFORM A PROPENSITY SCORE-MATCHED COHORT STUDY COMPARING THE PIPELINE EMBOLIZATION DEVICE TO COMPETITOR PRODUCTS. 221 INTERNAL CAROTID ARTERY ANEURYSMS WERE TREATED WITH PIPELINE. THE AVERAGE DIAMETER OF THE ANEURYSMS WAS 6.3MM, MEAN AGE OF 60, IN 191 FEMALE OF 221 TOTAL PATIENTS. THE STUDY TOOK PLACE BETWEEN 2013 AND 2017. COMPLICATIONS OCCURRED INCLUDING A NEED FOR BALLOON ANGIOPLASTY IN 16 PATIENTS, THROMBOEMBOLIC COMPLICATIONS IN 20 PATIENTS, HEMORRHAGIC COMPLICATIONS IN 5 PATIENTS, TRANSIENT VISUAL COMPLICATION IN 6 PATIENTS, AND A NEED FOR RETREATMENT IN 10 PATIENTS. 5 ALSO HAD A POOR FUNCTIONAL OUTCOME (MRS 3-5) AND 2 PATIENTS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030351 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death