BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-7-3FOR US

    MDR report key: 10341030 · Received July 29, 2020

    Report

    Report Number
    2032493-2020-00185
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    June 29, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006136
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. THE WEB WAS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ANEURYSM AT THE BASILAR APEX. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, THE WEB WOULD NOT DETACH. THE MICROCATHETER WAS ADVANCED TO ASSIST IN DETACHMENT; HOWEVER, DURING THE DETACHMENT, THE WEB ROTATED AND BLOCKED APPROXIMATELY 75% OF THE POSTERIOR CEREBRAL ARTERY (PCA). A STENT WAS IMPLANTED WITHOUT INCIDENT IN THE PCA TO SUCCESSFULLY RECANALIZE THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL CONSEQUENCE. THE PATIENT IS CURRENTLY REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803104 WEB LOW PROFILE SL-USA W4-7-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25070-030 17032904M 00854111006136

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention