BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 8719259 · Received June 20, 2019

    Report

    Report Number
    2032493-2019-00158
    Event Type
    Death
    Date Received
    June 20, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 21, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006068
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE MICROCATHETER WAS ADVANCED TO THE TREATMENT SITE AND THE WEB WAS PARTIALLY DEPLOYED WITHIN THE ANEURYSM. THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE WEB WAS SITTING, SO THE WEB WAS RESHEATHED AND AN ATTEMPT WAS MADE TO REPOSITION IT IN THE ANEURYSM. AT THAT TIME, IT WAS OBSERVED THAT THE PATIENT'S BLOOD PRESSURE HAD SPIKED. A CONTRAST INJECTION DEMONSTRATED THE ANEURYSM HAD RUPTURED. A BALLOON CATHETER WAS USED TO STOP THE BLEEDING. MULTIPLE COILS (NON-MICROVENTION) WERE SUBSEQUENTLY PLACED IN THE ANEURYSM AND AN EVD WAS PLACED. BLEEDING WAS CONTROLLED AND THE PATIENT WAS TAKEN TO THE ICU POST-OP. IT WAS LATER REPORTED THAT THE PATIENT HAD EXPIRED THREE (3) DAYS POST-PROCEDURE. SUBARACHNOID HEMORRHAGE WAS NOTED TO BE THE CAUSE OF DEATH. THE PHYSICIAN STATED THERE WAS NO MALFUNCTION OF THE WEB DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512976 WEB LOW PROFILE SL-USA W4-5-3FOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA25050-030 19030420 00854111006068

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| L| R