BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 8778872 · Received July 10, 2019

    Report

    Report Number
    2029214-2019-00722
    Event Type
    Injury
    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 DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED IN THE PATIENTS. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2019-00723. 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. OF THE 18 PATIENTS, 13 PATIENTS HAD BEEN UNDERGONE PED IMPLANTATION AS INITIAL TREATMENT. THE PED WAS NOTED TO HAVE FORESHORTENED IN TWO CASES. THE ARTICLE NOTES THE FOLLOWING COMPLICATIONS, WHICH OCCURRED DURING THE RETREATMENT PROCEDURE: 2 PATIENTS EXPERIENCED VASOSPASM AND UNDERWENT VERAPAMIL INFUSION. 2 PATIENTS EXPERIENCED PED THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571662 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R