BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 11917050 · Received June 1, 2021

    Report

    Report Number
    1226348-2021-00034
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    November 30, 2008
    Report Date
    May 12, 2021
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 1226348-2021-00033, 1226348-2021-00035 AND 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 EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVF) AND SUFFERED AN ASYMPTOMATIC INTERNAL CAROTID DISSECTION WHICH WAS TREATED WITH ANTICOAGULATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS N-BUTYL-2- CYANOACRYLATE (TRUFILL N-BCA). OTHER CNV DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. NON-CNV DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS: TITLE: ONYX VERSUS N-BCA FOR EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS. OBJECTIVE: TO EVALUATE THE EFFICACY OF N-BUTYL-2- CYANOACRYLATE (TRUFILL N-BCA) VERSUS ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) FOR THE EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVF). METHODS: FIFTY-THREE CONSECUTIVE PATIENTS WITH CRANIAL DURAL AVF WERE TREATED WITH LIQUID EMBOLIC AGENTS FROM NOVEMBER, 2003 TO NOVEMBER, 2008. THESE 53 PATIENTS HAD 56 LESIONS TREATED WITH ARTERIAL EMBOLIZATION. PATIENTS EMBOLIZED TO COMPLETION UNDERWENT FOLLOW-UP ANGIOGRAPHY AT 3 MONTHS TO ASSESS FOR DURABLE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807592 UNK LIQUID EMBOLIC TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention