BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-6-3FOR US

    MDR report key: 9827495 · Received March 12, 2020

    Report

    Report Number
    2032493-2020-00061
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 11, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006099
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCE ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE WEB WAS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES HEMORRHAGE AND VESSEL DISSECTION OR PERFORATION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON AN UNRUPTURED TERMINUS BIFURCATION ANEURYSM IN THE INTERNAL CAROTID ARTERY. AFTER DEPLOYMENT OF THE WEB, AN ANEURYSM RUPTURE AND SLOW BLEED WAS IDENTIFIED. A BALLOON WAS INFLATED AND THE BLEEDING STOPPED. THE PATIENT WAS REPORTED TO BE "AWAKE AND OK" WITH "NO HEADACHE" APPROXIMATELY ONE HOUR AFTER THE PROCEDURE. THE PATIENT IS CURRENTLY REPORTED TO BE DOING "GREAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290346 WEB LOW PROFILE SL-USA W4-6-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25060-030 18122103 00854111006099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention