BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9056928 · Received September 14, 2019

    Report

    Report Number
    2032493-2019-00222
    Event Type
    Injury
    Date Received
    September 14, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 15, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006136
    PMA / PMN Number
    P170023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THIS DEVICE. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED DURING THE SAME PROCEDURE REFERENCED IN MFR. REPORT # 2032493-2019-00223.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS ATTEMPTED ON AN ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM) WHICH HAD AN ACUTE TAKEOFF ANGLE FROM THE PARENT ARTERY. AFTER MULTIPLE ATTEMPTS, THE MICROCATHETER FINALLY GAINED ACCESS TO THE ANEURYSM FROM THE RIGHT INTERNAL CAROTID ARTERY (ICA); HOWEVER, THE WEB DEVICE WAS NOT OPENING ADEQUATELY, DESPITE SEVERAL DEPLOYMENT ATTEMPTS. THE MICROCATHETER AND WEB DEVICE WERE REMOVED. A NEW VIA 21 MICROCATHETER WAS SUCCESSFUL AT OBTAINING ACCESS TO THE ANEURYSM FROM THE LEFT ICA. DEPLOYMENT OF THE SAME WEB DEVICE WAS ATTEMPTED, BUT EFFORTS WERE UNSUCCESSFUL DUE TO DIFFICULT ANATOMY. DURING PARTIAL DEPLOYMENT OF THE WEB, A NEW ROADMAP IMAGE WAS OBTAINED, WHICH DEMONSTRATED AN ANEURYSM RUPTURE WITH CONTRAST EXTRAVASATION. THE WEB DEVICE WAS REMOVED AND THE ANEURYSM WAS PARTIALLY COILED THROUGH THE VIA MICROCATHETER, WHICH WAS EFFECTIVE AT CONTROLLING THE BLEEDING; HOWEVER, CHANGES IN THE PATIENT'S VITAL SIGNS WERE INDICATIVE OF A SUBARACHNOID HEMORRHAGE. THE ANEURYSM TREATMENT WAS STOPPED AT THIS POINT SO THAT AN EVD COULD BE PLACED. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND THE ANEURYSM WAS RETREATED WITH ANOTHER ENDOVASCULAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848274 WEB LOW PROFILE SL-USA W4-7-3FOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT OPR SEQUENT MEDICAL, INC FGA25070-030 19012304 00854111006136

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention