BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN LIQUID EMBOLIC

    MDR report key: 10684147 · Received October 15, 2020

    Report

    Report Number
    1226348-2020-00465
    Event Type
    Death
    Date Received
    October 15, 2020
    Date of Event
    May 21, 2019
    Report Date
    September 29, 2020
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4). CERENOVUS MANUFACTURER'S REPORT NUMBERS: 1226348-2020-00466 AND 1226348-2020-00467 ARE 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 1 PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE AND SUFFERED A POSTPROCEDURAL INTRAVENTRICULAR HEMORRHAGE LEADING TO DEATH. IT WAS REPORTED THAT THE PATIENT HAD TECHNICALLY AN UNCOMPLICATED EMBOLIZATION PROCEDURE. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS UNKNOWN NBCA. OTHER CNV DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. NON-CNV DEVICES THAT WERE ALSO USED IN THIS STUDY: ONYX, UNKNOWN BRAND OF COILS, APOLLO DETACHABLE CATHETER. PUBLICATION DETAILS: TITLE: VEIN OF GALEN MALFORMATIONS: THE TEXAS CHILDREN¿S HOSPITAL EXPERIENCE IN THE MODERN ENDOVASCULAR ERA. OBJECTIVE: TO RETROSPECTIVELY REVIEW PEDIATRIC PATIENTS WITH VOGM TREATED AT TEXAS CHILDREN¿S HOSPITAL (TCH), A QUATERNARY REFERRAL CENTER, OVER 15 YR, AND PRESENT LESSONS LEARNED IN TREATING CHILDREN WITH MODERN ENDOVASCULAR TECHNIQUES. METHODS: CHARTS FROM TCH WERE RETROSPECTIVELY REVIEWED FOR THE PAST 15 YR. PATIENTS WITH DIAGNOSIS INCLUDING ¿VEIN OF GALEN,¿ ¿VEIN OF GALEN MALFORMATION,¿ ¿VEIN OF GALEN ANEURYSMAL MALFORMATION,¿ OR ANY ABBREVIATIONS (IE, VOG, VOGM, VOGAM) WERE REVIEWED. PRESENTATION, IMAGING, TREATMENT SPECIFICS, AND CLINICAL OUTCOMES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151226 UNKNOWN LIQUID EMBOLIC UNKNOWN KGG CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death APOLLO DETACHABLE CATHETER| ONYX| UNKNOWN BRAND OF COILS