BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LIQUID EMBOLIC

    MDR report key: 22852744 · Received August 20, 2025

    Report

    Report Number
    3008114965-2025-00899
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    October 31, 2024
    Report Date
    August 20, 2025
    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 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: THIS STUDY REPORTED ONE CASE OF NONTARGET EMBOLIZATION WHICH REQUIRED SUCTIONING, LAVAGE AND BRONCHOPLASTY. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUNG ML, MA KC, LANFRANCO AR, CLARK TWI, VANCE AZ. PERIGRAFT ENDOLEAK EMBOLIZATION FOLLOWING STENT GRAFT REPAIR OF A PULMONARY ARTERY PSEUDOANEURYSM. J VASC INTERV RADIOL. 2025 FEB;36(2):363-366. DOI: 10.1016/J.JVIR.2024.10.027. EPUB 2024 OCT 31. PMID: 39486511. BACKGROUND: PULMONARY ARTERY PSEUDOANEURYSMS (PAPS) ARE RARE BUT SERIOUS VASCULAR ABNORMALITIES DEFINED AS FOCAL SACCULAR OUTPOUCHINGS OF THE PULMONARY ARTERY INVOLVING THE EXTERNAL LAYERS OF THE ARTERIAL WALL (1). ENDOVASCULAR THERAPY HAS EMERGED AS FIRST-LINE MANAGEMENT OWING TO ITS MINIMALLY INVASIVE NATURE AND DECREASED MORBIDITY; TECHNIQUES INCLUDE COIL EMBOLIZATION, STENT-GRAFT PLACEMENT, AND LIQUID EMBOLIC AGENTS (2). OBJECTIVE: THIS REPORT PRESENTS A PATIENT WHO DEVELOPED AN ENDOLEAK FOLLOWING PULMONARY ARTERY STENT-GRAFT PLACEMENT AND DESCRIBES THE STRATEGY TO EMBOLIZE THE ENDOLEAK AND RESIDUAL PAP. METHODS: THE PATIENT WAS A 42-YEAR-OLD WOMAN WITH METASTATIC CHOLANGIOCARCINOMA INCLUDING PULMONARY METASTASES TREATED WITH WEDGE RESECTIONS AND RIGHT HILAR NODAL METASTASIS TREATED WITH RADIATION, COMPLICATED BY RADIATIONINDUCED AIRWAY INJURY, WHICH REQUIRED REPEATED BRONCHOSCOPIES TO REMOVE NECROTIC MUCOSAL DEBRIS. TWO OVERLAPPING BALLOONEXPANDABLE STENT-GRAFTS (VBX; W. L. GORE, FLAGSTAFF, ARIZONA) WERE PLACED IN THE RIGHT INTERLOBAR ARTERY, DILATED TO 14 MM AT THE PROXIMAL ASPECT OF THE CONSTRUCT, AND TAPERED TO 9 MM DISTALLY. VIA A RIGHT COMMON FEMORAL VEIN APPROACH, AN 80¿CM, 8- F SHEATH WAS INTRODUCED COAXIALLY THROUGH A 14-F SHEATH AND POSITIONED IN THE RIGHT PULMONARY ARTERY FOR STABLE ACCESS. THE PERIGRAFT SPACE BETWEEN THE STENT-GRAFT CONSTRUCT AND ARTERIAL WALL WAS ACCESSED USING A 0.014-INCH MICROWIRE (FATHOM; BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS) AND MICROCATHETER (RENEGADE HI-FLO; BOSTON SCIENTIFIC) (FIG 2A). N-BUTYL CYANOACRYLATE (TRUFILL; JOHNSON & JOHNSON, NEW BRUNSWICK, NEW JERSEY) WAS MIXED WITH ETHIODIZED OIL (LIPIODOL; GUERBET, VILLEPINTE, FRANCE) IN A 1:2 RATIO, AND 2 ML WAS INJECTED THROUGH THE MICROCATHETER TO SEAL THE ENDOLEAK. CONCLUSIONS: HOWEVER, THE NONTARGET LEAKAGE OF THE LIQUID EMBOLIC INTO THE BRONCHIAL TREE ILLUSTRATES THAT THE EMBOLIC HAS NOT BEEN OPTIMIZED FOR THIS APPLICATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CNV DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: N-BUTYL CYANOACRYLATE (TRUFILL; JOHNSON & JOHNSON, NEW BRUNSWICK, NEW JERSEY). OTHER CNV PRODUCTS: NONE NON-CNV DEVICES: TWO OVERLAPPING BALLOONEXPANDABLE STENT-GRAFTS (VBX; W. L. GORE, FLAGSTAFF, ARIZONA), UNKNOWN MANUFACTURER 14-F SHEATH, 0.014-INCH MICROWIRE (FATHOM; BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS) AND MICROCATHETER (RENEGADE HI-FLO; BOSTON SCIENTIFIC) AND ETHIODIZED OIL (LIPIODOL; GUERBET, VILLEPINTE, FRANCE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR CNV DEVICES: QTY 1: 1 COMPLETION ARTERIOGRAPHY DEMONSTRATED NO NONTARGET EMBOLIZATION. THIS REQUIRED SUCTIONING. THE NONTARGET LEAKAGE OF THE LIQUID EMBOLIC INTO THE BRONCHIAL TREE ILLUSTRATES THAT THE EMBOLIC HAS NOT BEEN OPTIMIZED FOR THIS APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143858 UNK LIQUID EMBOLIC LIQUID EMBOLIC KGG MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention 0.014-INCH MICROWIRE (FATHOM, BOSTON SCIENTIFIC)| 14-F SHEATH (UNSPECIFIED BRAND)| BALLOON EXPANDABLE STENT-GRAFTS (VBX)| MICROCATHETER (RENEGADE HI-FLO, BOSTON SCIENTIFIC)