BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EMBOLIC FILTER

    MDR report key: 2492550 · Received March 9, 2012

    Report

    Report Number
    2017233-2012-00155
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 9, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE SITE AND THEREFORE A DEVICE ANALYSIS COULD NOT BE CONDUCTED. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. IMAGES WERE RETURNED FOR EVALUATION. THE IMAGES CONFIRMED THE DEVICE WAS SUCCESSFULLY ADVANCED AND DEPLOYED. MARKERS ON THE GEF APPEARED TO BE EVENLY SPACED. NO IMAGES SHOWING CONTRAST INJECTION WITH THE GEF DEPLOYED WERE AVAILABLE. ADDITIONALLY, NO MEASUREMENTS WERE GENERATED AS THE AVAILABLE IMAGES WERE NOT CALIBRATED.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY. A GORE EMBOLIC FILTER WAS USED FOR EMBOLIC PROTECTION. IT WAS REPORTED THE PATIENT SUFFERED A STROKE POST-STENT DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EMBOLIC FILTER NTE / TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE W.L. GORE & ASSOCIATES WLG395 9371878

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other ACCULINK CAROTID STENT