BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-5-3FOR US

    MDR report key: 10411630 · Received August 14, 2020

    Report

    Report Number
    2032493-2020-00208
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 17, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006068
    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. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PARENT ARTERY OCCLUSION, VASCULAR THROMBOSIS, NEUROLOGIC DEFICITS, AND DEVICE MIGRATION OR MISPLACEMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE WEB WAS IMPLANTED IN AN ACOM ANEURYSM, THE DEVICE PROTRUDED INTO THE PARENT ARTERY APPROXIMATELY 40-50%; HOWEVER, THE A2 WAS FILLING NICELY. AFTER THE PATIENT WOKE UP POST-PROCEDURE, HE HAD RIGHT SIDED WEAKNESS THAT WORSENED. THE PATIENT WAS BROUGHT BACK TO THE ANGIO SUITE AND ANGIOGRAPHY DEMONSTRATED CLOT ON THE WEB THAT EXTENDED INTO THE A2. TPA WAS DELIVERED TO THE PATIENT, WHICH DISSOLVED THE CLOT. FINAL ANGIOGRAMS LOOKED GOOD. POST-OPERATIVELY, THE PATIENT WAS PLACED ON A HEPARIN DRIP AND PRESCRIBED ASPIRIN AND PLAVIX. THERE WAS NO SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872360 WEB LOW PROFILE SL-USA W4-5-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25050-030 20022612X 00854111006068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention