BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB LOW PROFILE SLS-USA W4-5-SFOR US

    MDR report key: 9298617 · Received November 8, 2019

    Report

    Report Number
    2032493-2019-00262
    Event Type
    Death
    Date Received
    November 8, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 10, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006013
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. HOWEVER, TORTUOUS VASCULATURE AND ANGLE ALIGNMENT WAS REPORTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ANEURYSM PERFORATION OR RUPTURE, HEMORRHAGE, VESSEL DISSECTION OR PERFORATION, AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE. THIS DEVICE IS ASSOCIATED WITH THE SAME PROCEDURE AS REPORTED IN MFR REPORT # 2032493-2019-00261.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS REPORTED TO BE TORTUOUS. AN ATTEMPT WAS MADE TO RETRACT THE WEB DEVICE INTO THE VIA MICROCATHETER FOR REPOSITIONING IN THE ANEURYSM. ADDITIONAL FORCE WAS REQUIRED TO RECAPTURE THE WEB INTO THE VIA DUE TO THE VESSEL TORTUOSITY AND THE ANGLE OF THE MICROCATHETER IN RELATION TO THE PROXIMAL MARKER OF THE WEB DEVICE. AT THE TIME THE WEB WAS WITHDRAWN INTO THE VIA, THE VIA "JUMPED" FORWARD. THE MICROCATHETER WAS PULLED BACK AND AN ANGIOGRAPHY RUN DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM. HEPARIN WAS REVERSED AND PROTAMINE WAS ADMINISTERED. THE VIA AND WEB WERE REMOVED TOGETHER, A NEW MICROCATHETER WAS PLACED, AND THREE (3) EMBOLIZATION COILS WERE IMPLANTED IN THE ANEURYSM, WHICH STOPPED THE BLEEDING; HOWEVER, THE PATIENT DEVELOPED INTRACRANIAL HYPERTENSION DURING THE PROCEDURE, AND BOTH PUPILS WERE NOTED TO BE DILATED AND UNRESPONSIVE. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT NEVER REGAINED CONSCIOUSNESS AND DIED FOUR DAYS LATER. THE CAUSE OF DEATH WAS DETERMINED BY THE PHYSICIAN TO BE "HIGH INTRACRANIAL PRESSURE WITH CENTRAL HERNIATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093022 WEB LOW PROFILE SLS-USA W4-5-SFOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA25050-001 19050370 00854111006013

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R VIA 21 MICROCATHETER