BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 22794908 · Received August 13, 2025

    Report

    Report Number
    3008114965-2025-00872
    Event Type
    Injury
    Date Received
    August 13, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Product Problem
    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 NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. SECTION H4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. 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 PATIENT WITH AN OCCLUSION OF THE ULNAR ARTERY WHICH REQUIRED A SURGICAL INTERVENTION; 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 FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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 (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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: JOSEPH C., JOSE AMH., DANYAL K. TRANSCATHETER EMBOLIZATION OF AORTOPULMONARY COLLATERALS USING THE TRUFILL® N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM; A SINGLE-CENTER EXPERIENCE. PROGRESS IN PEDIATRIC CARDIOLOGY 78 (2025) 101855. HTTPS://DOI.ORG/10.1016/J.PPEDCARD.2025.101855. BACKGROUND: AORTOPULMONARY COLLATERALS (APCS) ARE COMMONLY FOUND IN PATIENTS WITH CYANOTIC HEART DISEASE. THESE APCS COMPETE WITH NORMAL PULMONARY BLOOD FLOW IN PATIENTS WHO HAVE UNDERGONE GLENN OR FONTAN SURGERY. APCS ARE ALSO SEEN IN PATIENTS WITH CYSTIC FIBROSIS (CF), WHERE THEY ARE KNOWN TO CAUSE HEMOPTYSIS. TRANSCATHETER OCCLUSION OF APCS HAS PREVIOUSLY BEEN DESCRIBED USING COILS, VASCULAR PLUGS, AND POLYVINYL ALCOHOL (PVA) PARTICLES. WE PRESENT A SERIES OF PATIENTS IN WHICH THE APCS WERE EMBOLIZED USING TRUFILL N-BCA LIQUID. OBJECTIVES: THIS STUDY AIMS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TRUFILL® N-BUTYLCYANOACRYLATE (N-BCA) FOR TRANSCATHETER EMBOLIZATION OF AORTOPULMONARY COLLATERAL VESSELS IN PATIENTS WITH CONGENITAL HEART DISEASE AND CYSTIC FIBROSIS, PARTICULARLY IN CASES WHERE TRADITIONAL EMBOLIZATION METHODS ARE LIMITED OR IN PATIENTS WITH SIGNIFICANT HEMOPTYSIS. METHODS: FROM 2009 TO 2012, A TOTAL OF 18 CATHETERIZATION PROCEDURES WERE PERFORMED (IN 15 PATIENTS), IN WHICH APCS WERE EMBOLIZED USING N-BCA. THE MEAN AGE WAS 8.5 YEARS (RANGE: 4 MONTHS TO 21 YEARS), WITH A MEAN WEIGHT OF 29 KG (RANGE: 7¿72 KG). THREE PATIENTS HAD CYSTIC FIBROSIS (CF) AND PRESENTED WITH HEMOPTYSIS. THE REMAINING PATIENTS HAD CYANOTIC CONGENITAL HEART DISEASE AND HAD UNDERGONE BIDIRECTIONAL GLENN OR FONTAN PROCEDURES. ONE OF THE CONGENITAL HEART DISEASE PATIENTS HAD TWO CATHETERIZATION PROCEDURES (2.5 YEARS APART) FOR HEMOPTYSIS. CONCLUSION: N-BCA IS A LIQUID EMBOLIC AGENT THAT IS FDA-APPROVED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS. PVA PARTICLES, PREVIOUSLY USED FOR CEREBRAL AVMS, HAVE A HIGH RECANALIZATION RATE AND HAVE THEREFORE BEEN REPLACED BY TRUFILL N-BCA OR ONYX LIQUID EMBOLIC SYSTEMS. APCS HAVE BEEN EMBOLIZED USING COILS, VASCULAR PLUGS, AND PVA PARTICLES¿ALL OF WHICH ARE ASSOCIATED WITH VARYING RATES OF RECANALIZATION. WE BELIEVE THAT N-BCA PROVIDES A MORE PERMANENT FORM OF APC OCCLUSION WITH A DECREASED INCIDENCE OF RECANALIZATION. HOWEVER, CAUTION SHOULD BE EXERCISED, ESPECIALLY WHEN EMBOLIZING ARTERIES OR APCS THAT MAY HAVE BRANCHES EXTENDING TO SUBCUTANEOUS TISSUE, AS N-BCA MAY BE LESS FORGIVING COMPARED TO OTHER OCCLUSION METHODS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRUFILL® N-BUTYLCYANOACRYLATE (N-BCA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR [TRUFILL® N-BUTYLCYANOACRYLATE (N-BCA)]: -QTY: 1 PATIENT HAD COMPLICATION DURING EMBOLIZATION OF AN AORTOPULMONARY COLLATERAL (APC) FROM THE RIGHT INTERNAL MAMMARY ARTERY. A PORTION OF THE N-BCA MIXTURE EMBOLIZED TO THE ULNAR ARTERY, CAUSING PARTIAL OCCLUSION. THE PATIENT HAD A PREVIOUSLY OCCLUDED RADIAL ARTERY, ELIMINATING COLLATERAL FLOW TO THE RIGHT HAND. VASCULAR SURGERY SUCCESSFULLY REMOVED THE EMBOLUS, WITH NO RESIDUAL MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79804 UNK LIQUID EMBOLIC LIQUID EMBOLIC KGG MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention