BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-4-3FOR US

    MDR report key: 9662629 · Received February 3, 2020

    Report

    Report Number
    2032493-2020-00020
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 4, 2020
    Report Date
    January 4, 2020
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006044
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICE WAS IMPLANTED IN THE PATIENT. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RUPTURED ANTERIOR COMMUNICATING ARTERY (PERICALLOSAL) ANEURYSM. THE PATIENT HAD NOT BEEN GIVEN ANTICOAGULANT MEDICATION BEFORE THE PROCEDURE. A POST-DEPLOYMENT ANGIOGRAM DEMONSTRATED NORMAL FLOW IN THE A-COM ARTERY; HOWEVER, A CLOT WAS IDENTIFIED AT THE NECK OF THE ANEURYSM AND ON THE WEB DEVICE. A BOLUS OF INTEGRILIN WAS ADMINISTERED AND FULL FLOW WAS RESTORED. THERE WAS NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123994 WEB LOW PROFILE SL-USA W4-4-3FOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA25040-030 19081929 00854111006044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention