BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 25317914 · Received May 28, 2026

    Report

    Report Number
    3008114965-2026-00751
    Event Type
    Injury
    Date Received
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SECTION D4: UDI: AS THE CATALOG/MODEL NUMBERS WERE 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: REGARDING THE CASES OF STROKE, CRANIAL NERVE PALSY, SEIZURES, AND RETREATMENT WITHIN 2 WEEKS (SUBDURAL HEMATOMA RECURRENCE), SINCE THE EVENTS ARE LIFE THREATENING AND MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR REQUIRED SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEY ARE TO BE CONSIDERED SERIOUS. THE EVENTS ARE REPORTABLE TO THE US FDA. REGARDING THE EVENTS OF 30-DAY HOSPITAL READMISSION AND 90-DAY HOSPITAL READMISSION, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE HOSPITAL READMISSIONS WERE RELATED TO THE DEVICE AND/OR PROCEDURE DIRECTLY. THEREFORE, THE EVENTS ARE NOT REPORTABLE TO THE USFDA. 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. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GUNN KJ, SLEASMAN E, AKKIPEDDI SMK, ROMIYO P, DAVIS E, VALDES BARRERA P, MENDOZA-AYUS S, DHAR V, SCHARTZ D, NGUYEN VN, BHALLA T, MATTINGLY T, BENDER MT. SUPPLY COST AND OUTCOME COMPARISON OF NBCA, ONYX, AND COILS FOR MIDDLE MENINGEAL ARTERY EMBOLIZATIONS: A SINGLE-CENTER RETROSPECTIVE ANALYSIS. J NEUROINTERV SURG. 2025 OCT 5:JNIS-2025-024003. DOI: 10.1136/JNIS-2025-024003. EPUB AHEAD OF PRINT. PMID: 41047222. OBJECTIVE/METHODS/STUDY DATA: THIS SINGLE- INSTITUTION, RETROSPECTIVE STUDY AIMED TO COMPARE THE SUPPLY COSTS OF MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATIONS USING NBCA, ONYX, AND/OR COILS. BETWEEN AUGUST 2023 TO FEBRUARY 2025, A TOTAL OF 99 PATIENTS UNDERGOING 100 MMA EMBOLIZATIONS FOR THE TREATMENT OF SUBDURAL HEMATOMAS (SDHS) WERE ANALYZED IN THE STUDY. SUPPLIES USED WERE CATHETERS, MICROCATHETERS, GUIDEWIRES, EMBOLIC AGENTS SUCH AS NBCA, ONYX, COILS. THERE WERE FIVE VARIATIONS OF EMBOLIC AGENTS USED IN THE 98 PROCEDURES. SIXTY- THREE EMBOLIZATIONS WERE PERFORMED WITH NBCA, 26 WITH ONYX, TWO WITH COILS, TWO WITH NBCA AND COILS, AND SEVEN WITH ONYX AND COILS. THERE WAS A TOTAL OF 42 BILATERAL PROCEDURES, WITH AN AVERAGE OF 2.2±1.0 PEDICLES EMBOLIZED PER PROCEDURE. OVERALL, PROCEDURES TOOK AN AVERAGE OF 84.4±33.9 MIN WITH RADIAL ACCESS BEING THE MOST COMMON APPROACH. AVERAGE FOLLOW-UP DURATION WAS 233.1 DAYS (MEDIAN 139.5 DAYS, IQR 78.5¿303.2). THE AVERAGE IMAGING FOLLOW- UP DURATION WAS 169 DAYS (MEDIAN 104.5 DAYS, IQR 54.8¿226). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: N-BUTYL CYANOACRYLATE BASED TRUFILL (NBCA) OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: COILS (MANUFACTURED BY STRYKER), CATHETERS, MICROCATHETERS, MICROWIRES (NOT SPECIFIED), ONYX ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK LIQUID EMBOLIC (QTY 29): QTY 3: 3 CASES OF STROKE. INTERVENTION WAS NOT DISCUSSED. QTY 2: 2 CASES OF CRANIAL NERVE PALSY. INTERVENTION WAS NOT DISCUSSED. QTY 3: 3 CASES OF SEIZURE. INTERVENTION WAS NOT DISCUSSED. QTY 2: 2 CASES OF RETREATMENT (WITHIN 2 WEEKS). INTERVENTION WAS NOT DISCUSSED. QTY 13: 13 CASES OF 30-DAY HOSPITAL READMISSION. INTERVENTION WAS NOT DISCUSSED. QTY 6: 6 CASES OF 90-DAY HOSPITAL READMISSION. INTERVENTION WAS NOT DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487855 UNK LIQUID EMBOLIC LIQUID EMBOLIC KGG MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1