BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 20065759 · Received August 26, 2024

    Report

    Report Number
    3008114965-2024-00848
    Event Type
    Injury
    Date Received
    August 26, 2024
    Report Date
    June 17, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. CLINICIAN ASSESSMENT: SINCE THE EVENT REQUIRED SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS. THE EVENT IS REPORTABLE TO THE US FDA. THE COMPLAINT WILL BE UPDATED WITH ANY ADDITIONAL INFORMATION RECEIVED FROM PERFORMING FOLLOW-UP ACTIVITY WITH THE CORRESPONDING AUTHOR, AND REPORTABILITY FOR THE US FDA WILL BE REASSESSED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H3, H6 AND H11. THIS FILE WAS RE-ASSESSED ON 17-JUN-2025. THE ARTICLE MENTIONS THE USE OF N-BCA LIQUID EMBOLIC AGENT BUT DOES NOT SPECIFY CERENOVUS AS THE MANUFACTURER. FURTHER, THE ADDITIONAL INFORMATION FROM AUTHOR RECEIVED ON 13-AUG-2024, STATES THERE WAS NO RELEVANCE BETWEEN THE HARM AND THE JNJ PRODUCT IN THE ARTICLE. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE TO THE USFDA.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: FAN XD, SU LX, ZHENG JW, ZHENG LZ, ZHANG ZY. ETHANOL EMBOLIZATION OF ARTERIOVENOUS MALFORMATIONS OF THE MANDIBLE. AJNR AM J NEURORADIOL. 2009 JUN;30(6):1178-83. DOI: 10.3174/AJNR.A1539. EPUB 2009 MAR 6. PMID: 19270102; PMCID: PMC7051317. BACKGROUND AND PURPOSE: ABSOLUTE ETHANOL WAS REPORTED AS AN EFFECTIVE EMBOLIZATION OF ARTERIOVENOUS MALFORMATIONS (AVMS), BUT ITS USE TO TREAT AVMS IN THE MANDIBLE IS NOT YET WELL ESTABLISHED. HERE, WE PRESENT OUR CLINICAL EXPERIENCE ON TREATMENT OF MANDIBULAR AVMS WITH ABSOLUTE ETHANOL. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: QTY UNK: TRUFILL N-BCA NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH THE TRUFILL N-BCA: QTY (B)(4): PATIENT #1 (13YO/M) HAD RECURRENT LESIONS (REPEATED BLEEDING) WHICH PROGRESSED BILATERALLY AFTER EMBOLIZATION WITH COILS AND N-BCA TWO YEARS AGO. PATIENT WAS RETREATED WITH SECOND SURGICAL PROCEDURE. (NO ALLEGED QUALITY ISSUE/ HEMORRHAGE/TREATMENT FAILURE & SURGICAL INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277495 UNK LIQUID EMBOLIC LIQUID EMBOLIC KGG MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Life Threatening| R