BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIQUID EMBOLIC

    MDR report key: 10775025 · Received November 2, 2020

    Report

    Report Number
    1226348-2020-00469
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    December 31, 2017
    Report Date
    October 22, 2020
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CERENOVUS MANUFACTURER'S REPORT NUMBER: 1226348-2020-00470. IS RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 3 PATIENTS UNDERWENT ARTERIOVENOUS MALFORMATION EMBOLIZATION AND SUFFERED TRANSIENT NEUROLOGICAL DEFICITS FOLLOWING EMBOLIZATION WITH USE OF THE NBCA TRUFILL GLUE. NO INTERVENTION WAS REPORTED. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS NBCA TRUFILL OTHER CNV THAT WERE ALSO USED IN THIS STUDY: ENVOY CATHETER NON-CNV DEVICES THAT WERE ALSO USED IN THIS STUDY: APOLLO MICROCATHETER, MARATHON MICROCATHETER, 058 NAVIEN, COOK SHUTTLE, ONYX. PUBLICATION DETAILS: TITLE: NEUROPHYSIOLOGICAL MONITORING DURING ARTERIOVENOUS MALFORMATION EMBOLIZATION. OBJECTIVE: TO REVIEW OUR USE OF NPM DURING AVM EMBOLIZATION TO BETTER DEFINE ITS UTILITY. METHODS: WE RETROSPECTIVELY EXAMINED AVM EMBOLIZATION CASES FROM 2004 TO 2017. WE RECORDED PATIENT AND AVM CHARACTERISTICS AS WELL AS OUTCOMES. WE THEN REVIEWED NPM RESULTS FROM EACH CASE, INCLUDING SOMATOSENSORY EVOKED POTENTIALS AND ELECTROENCEPHALOGRAM. OUR PRIMARY OUTCOME WAS POSTOPERATIVE NEUROLOGICAL DEFICIT, AND SECONDARY OUTCOMES WERE DISCHARGE AND 30-D MODIFIED RANKIN SCORE (MRS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240441 UNKNOWN LIQUID EMBOLIC TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other