BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 7449961 · Received April 23, 2018

    Report

    Report Number
    2029214-2018-00319
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    April 24, 2017
    Report Date
    April 22, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEREJO, R., BAIN, M., MOORE, N., HARDMAN, J., BAUER, A., HUSSAIN, M. S., . . . TOTH, G. (2017). FLOW DIVERTER TREATMENT OF INTRACRANIAL VERTEBRAL ARTERY DISSECTING PSEUDOANEURYSMS. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 9(11), 1064-1068. DOI:10.1136/NEURINTSURG-2017-013020 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORT THAT PATIENTS EXPERIENCED STROKE AFTER PIPELINE IMPLANTATION. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE USE OF FLOW DIVERTERS STENTS IN INTRACRANIAL VERTEBRAL ARTERY DISSECTING PSEUDOANEURYSMS. THE AUTHORS RETROSPECTIVELY ANALYZED 8 ANEURYSMS IN 7 CASES CASES IN WHICH PIPELINE EMBOLIZATION DEVICES (PEDS) WERE USED FOR THE TREATMENT OF INTRACRANIAL VERTEBRAL ARTERY DISSECTING PSEUDOANEURYSMS. OF THE 7 PATIENTS, 5 WERE FEMALE AND 2 WERE MALE, MEDIAN AGE WAS 47 YEARS. THE ARTICLE STATES THAT TWO PATIENTS EXPERIENCED SMALL PERIPROCEDURAL STROKES WITH TRANSIENT NEUROLOGIC DEFICIT: - THE FIRST PATIENT EXPERIENCED CEREBELLAR STROKE WITHIN 24 HOURS OF THE PROCEDURE; THE PATIENT HAD IN-STENT THROMBOSIS DISTAL TO THE PICA ORIGIN IN THE NON-DOMINANT VERTEBRAL ARTERY DESPITE ADEQUATE PLATELET INHIBITION. - THE SECOND PATIENT EXPERIENCED MILD POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) STROKE. IN THAT PATIENT, THE ARTICLE NOTES THAT THE PED COVERED THE PICA ORIGIN BUT PATENCY OF THE PICA WAS PRESERVED. THE PATIENT REPORTEDLY HAD EXCELLENT RECOVERY WITHOUT EVIDENCE OF PICA VESSEL COMPROMISE. THE ARTICLE STATESTHAT ALL PATIENTS HAD GOOD CLINICAL OUTCOME (MRS = 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295272 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other