BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10255851 · Received July 9, 2020

    Report

    Report Number
    2032493-2020-00161
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 10, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006068
    PMA / PMN Number
    P170023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES 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 NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEVICE MIGRATION OR MISPLACEMENT, PREMATURE OR DIFFICULT DEVICE DETACHMENT, AND DIFFICULT DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ACOM ANEURYSM. AFTER PLACEMENT OF THE WEB DEVICE, DETACHMENT WAS INITIATED WITH THE CONTROLLER; HOWEVER, THE WEB MOVED BACK WITH THE DELIVERY WIRE AS IT WAS BEING WITHDRAWN. MULTIPLE ATTEMPTS WERE MADE TO DETACH THE WEB BY MANIPULATING THE DEVICE WITH THE MICROCATHETER, THE DELIVERY WIRE, AND WITH THE DETACHMENT CONTROLLER. AS A RESULT OF THE MANIPULATIONS, THE PROXIMAL PORTION OF THE WEB HERNIATED INTO THE PARENT ARTERY. A STENT WAS DEPLOYED TO ENSURE PROPER PLACEMENT OF THE WEB IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719294 WEB LOW PROFILE SL-USA W4-5-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25050-030 20020311L 00854111006068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention