BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 12006427 · Received June 16, 2021

    Report

    Report Number
    2032493-2021-00232
    Event Type
    Injury
    Date Received
    June 16, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. THE DEVICE WAS IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONALLY, POST PROCEDURAL IMAGES WERE NOT PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED. THE IFU IDENTIFIES ISCHEMIC STROKE AND NEUROLOGIC DEFICITS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE ARTICLE TITLED, "ENDOVASCULAR TREATMENT OF SMALL AND VERY SMALL INTRACRANIAL ANEURYSMS WITH A WEB DEVICE," POST SUCCESSFUL INTRACRANIAL ANEURYSM TREATMENT WITH EITHER A SL 3 OR A SL 3.5 WEB DEVICE (DATES UNKNOWN), 2 PATIENTS WERE REPORTED TO HAVE SUFFERED A NEUROLOGIC DEFICIT, AND DWI REVEALED SMALL PUNCTIFORM ISCHEMIC SPOTS. THE FIRST PATIENT WAS TREATED WITH ABCIXIMAB, AND DWI SPOTS WERE LOCATED IN THE TERRITORY OF THE BRANCH WHERE THE CLOT HAD BEEN SEEN. IN THE SECOND CASE, NO INTRAOPERATIVE THROMBOEMBOLIC COMPLICATIONS WERE DEPICTED, AND MR IMAGING REVEALED 4 DWI SPOTS IN THE MIDDLE CEREBRAL ARTERY TERRITORY. DEFICITS WERE ALL COMPLETELY REGRESSIVE AT THE PATIENTS' DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908614 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1