BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-4-3FOR US

    MDR report key: 8702160 · Received June 14, 2019

    Report

    Report Number
    2032493-2019-00154
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006044
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORDS INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WEB DEVICE WAS BEING USED TO TREAT AN ANEURYSM THAT CAME OFF THE ANTERIOR COMMUNICATING ARTERY (ACOM) AT AN APPROXIMATE 45-DEGREE ANGLE. THE A-1 WAS STRAIGHT, BUT THERE WAS SOME PROXIMAL TORTUOSITY. THE WEB WAS ADVANCED INTO THE ANEURYSM AND DURING DEPLOYMENT, IT BECAME APPARENT THE ANEURYSM RUPTURED; HOWEVER, THE EXACT LOCATION OF THE RUPTURE WAS UNKNOWN. THE WEB WAS DEPLOYED IN THE A-1 TO CAUSE STASIS AND ESSENTIALLY ACTED AS A BALLOON, ELIMINATING FLOW TO THE RUPTURE SITE. THE WEB WAS RESHEATHED AND A SUBSEQUENT CONTRAST INJECTION WAS PERFORMED TO IDENTIFY THE RUPTURE SITE, WHICH WAS DETERMINED TO BE AT THE DOME OF THE ANEURYSM AT THE SHALLOWEST PART. THE WEB WAS THEN ADVANCED UP TO THE NECK OF THE ANEURYSM AND DEPLOYED PARTIALLY UNTIL THE DISTAL END WAS FLOWERED AND ATRAUMATIC, THE ENTIRE SYSTEM WAS MOVED FORWARD UNTIL THE WEB WAS IN THE ANEURYSM, AND THEN IT WAS COMPLETELY DEPLOYED. THE WEB PARTIALLY IMPINGED ON BOTH A-2S, ONE ABOUT 20% AND ONE APPROXIMATELY 70%. NO FURTHER INTERVENTION WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT HAD SOME SIGNIFICANT NEUROLOGICAL DEFICITS, BUT CONTINUED TO IMPROVE EVERY DAY. THE PATIENT CURRENTLY IS ESSENTIALLY "FINE" WITH ONLY SOME VERY MINOR NEUROLOGICAL DEFICIT AND IS PREPARING TO LEAVE THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492118 WEB LOW PROFILE SL-USA W4-4-3FOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA25040-030 19032002 00854111006044

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S