BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL

    MDR report key: 8462772 · Received March 28, 2019

    Report

    Report Number
    2032493-2019-00069
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 26, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006068
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REMAINS IMPLANTED; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS BEING PERFORMED FOR AN UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM. ACCESS TO THE TREATMENT SITE AND POSITIONING OF THE WEB IN THE ANEURYSM WERE ACCOMPLISHED WITHOUT INCIDENT. AFTER PLACEMENT OF THE WEB, THERE WAS DIFFICULTY MAINTAINING THE PATIENT'S AIRWAY, AND IT APPEARED THAT THE LEFT LUNG HAD COLLAPSED. THE WEB WAS DETACHED, AND FOLLOW-UP ANGIOGRAPHY CONFIRMED PROPER PLACEMENT. NO CONTRAST EXTRAVASATION WAS NOTED AT THAT TIME. THE PROCEDURE WAS PAUSED FOR SEVERAL MINUTES TO MANAGE THE PATIENT'S AIRWAY. UPON RESUMING THE PROCEDURE, ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM. A SCEPTER OCCLUSION BALLOON WAS PLACED AND INFLATED AT THE NECK OF THE ANEURYSM FOR APPROXIMATELY 3 MINUTES, OCCLUDING THE ANEURYSM. DURING DEFLATION OF THE BALLOON, IT APPEARED THAT THE WEB SHIFTED POSITION, OCCLUDING TWO MCA M2 DIVISIONS; THEREFORE, AN ATLAS STENT WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM TO SECURE THE WEB IN THE ANEURYSM TO ALLOW THE MCA BRANCHES TO REMAIN PATENT. THE PROCEDURE WAS COMPLETED WITH SATISFACTORY PLACEMENT OF THE WEB AND NO EVIDENCE OF ACTIVE EXTRAVASATION. POST-PROCEDURE MRA WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE, WHICH DEMONSTRATED SMALL FOCAL DEFICITS IN THE FRONTAL LOBE AND BLOOD IN THE SUBARACHNOID SPACE. THE PATIENT WAS MOVED TO THE ICU, AWOKE, WAS EXTUBATED, AND WAS ABLE TO MOVE ALL LIMBS. FOR TWO DAYS FOLLOWING THE PROCEDURE, PATIENT STATUS FOLLOW-UPS FROM THE PHYSICIAN INDICATED THE PATIENT WAS RECOVERING AND STILL IN THE ICU. THE PERI-PROCEDURAL HEMORRHAGE WAS DETERMINED TO BE A PROCEDURE-RELATED INCIDENT FROM THE ANESTHESIA RELATED COMPLICATIONS. POST-PROCEDURE, THE PATIENT HAD A FULL NEUROLOGICAL RECOVERY ALMOST TO BASELINE. PRIOR TO DISCHARGE, THE PATIENT EXPIRED FROM ACUTE LIVER AND KIDNEY FAILURE DUE TO HER PREVIOUS MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255839 WEB LOW PROFILE SL WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA25050-030 18122102 00854111006068

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| O| R