BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 8778877 · Received July 10, 2019

    Report

    Report Number
    2029214-2019-00723
    Event Type
    Death
    Date Received
    July 10, 2019
    Date of Event
    June 1, 2018
    Report Date
    July 10, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. BASED ON THE REPORTED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MDRS RELATED TO THIS EVENT: 2029214-2019-00722. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BENDER, M., VO, C., JIANG, B., CAMPOS, J., ZARRIN, D., XU, R., COON, A. (2018). PIPELINE EMBOLIZATION FOR SALVAGE TREATMENT OF PREVIOUSLY STENTED RESIDUAL AND RECURRENT CEREBRAL ANEURYSMS. INTERVENTIONAL NEUROLOGY, 7 (6), 359-369. DOI:10.1159/000489018. MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF COMPLICATIONS DURING OR AFTER PIPELINE PLACEMENT. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE SAFETY AND EFFECTIVENESS OF THE PIPELINE FOR PERSISTENT AND RECURRENT ANEURYSMS PREVIOUSLY TREATED. THE AUTHORS REVIEWED THE RESULTS OF 18 PATIENTS, AVERAGE AGE WAS 57 YEARS AND 80% WERE FEMALE. ALL 18 PATIENTS HAD UNDERGONE INITIAL TREATMENT, EXPERIENCED ANEURYSM RECURRENCE, THEN UNDERWENT RETREATMENT IN WHICH PIPELINE (PED) DEVICES WERE PLACED. THE ARTICLE NOTES THE FOLLOWING COMPLICATIONS POST-RETREATMENT: PATIENT 11: THE PATIENT HAD UNDERGONE FLOW DIVERSION TREATMENT OF A 21MM MID-BASILAR FUSIFORM ANEURYSM, THEN UNDERWENT PED RETREATMENT. FOUR YEARS AFTER RETREATMENT, THE PATIENT STOPPED TAKING CLOPIDOGREL AND EXPERIENCED A BRAIN STEM STROKE SHORTLY AFTER. CT ANGIOGRAPHY SHOWED LACK OF CONTRAST OPACIFICATION AT THE PROXIMAL END OF THE DEVICE SUGGESTIVE OF IN-STENT THROMBOSIS. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571667 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death