BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 7448239 · Received April 20, 2018

    Report

    Report Number
    2029214-2018-00311
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    October 18, 2017
    Report Date
    April 20, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    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., JOHN, S., HARDMAN, J., MOORE, N., HUSSAIN, M. S., <(>&<)> TOTH, G. (2017). FLOW DIVERTER TREATMENT OF CEREBRAL BLISTER ANEURYSMS. NEURORADIOLOGY, 59(12), 1285-1290. DOI:10.1007/S00234-017-1936-6 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 REPORTS OF PATIENT COMPLICATIONS AFTER PIPELINE PLACEMENT. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE USE OF FLOW-DIVERTER TREATMENT OF BLOOD BLISTER-LIKE ANEURYSMS. THE AUTHORS RETROSPECTIVELY REVIEWED EIGHT PATIENTS WHO UNDERWENT PIPELINE PLACEMENT IN THE TREATMENT OF RUPTURED BLOOD BLISTER-LIKE ANEURYSM. OF THE 8 PATIENTS, 5 WERE FEMALE AND THE MEDIAN AGE WAS 49 YEARS. THE ARTICLE STATES THAT THE FOLLOWING RESULTS WERE OBSERVED: PATIENT 8 ((B)(6), FEMALE) UNDERWENT PLACEMENT OF TWO PIPELINE DEVICES IN THE TREATMENT OF A SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) BLOOD BLISTER-LIKE ANEURYSM. THE PATIENT REPORTED EXPERIENCED A POST-PROCEDURAL ISCHEMIC STROKE. THE ARTICLE NOTES THAT THE PIPELINE HAD COVERED THE ORIGIN OF THE ANTERIOR CHOROIDAL ARTERY; HOWEVER, THERE WERE NO BRANCH OCCLUSIONS OR SLOW FLOW NOTED IN ANY VISUALIZED VESSELS. IMAGING SHOWED A SMALL STROKE IN THE CAUDATE HEAD. MRS WAS 3 ONE YEAR LATER. PATIENT 6 ((B)(6), MALE) UNDERWENT PLACEMENT OF TWO PIPELINE DEVICES IN THE TREATMENT OF A SUPRACLINOID ICA BLOOD BLISTER-LIKE ANEURYSM. THE PATIENT EXPERIENCED SPINAL EPIDURAL HEMATOMA, WHICH THE AUTHORS PRESUMED TO BE DUE TO ANTIPLATELET THERAPY. THE PATIENT'S SYMPTOMS WERE PAIN AND PARAPARESIS AND WAS TREATED CONSERVATIVELY. THE PATIENT MADE A GOOD RECOVERY; MRS WAS 2 ONE YEAR LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289274 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other