BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL

    MDR report key: 23429973 · Received October 30, 2025

    Report

    Report Number
    3007628272-2025-00054
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 20, 2025
    Report Date
    October 30, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE EXPIRATION DATE. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. CEREBRAL HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH TRUFILL N-BCA LIQUID EMBOLIC AGENT AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WAS NO ALLEGED QUALITY ISSUE RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE IFU DETAILS THAT THE APPROXIMATE POLYMERIZATION TIME FOR A 1:1 RATIO OF ETHIODIZED OIL TO N-BCA IS LESS THAN TWO SECONDS. ADDITIONALLY, THE IFU STATES, ¿AFTER INJECTION IS COMPLETED, IMMEDIATELY ASPIRATE WITH THE INJECTION SYRINGE AND RAPIDLY WITHDRAW THE CATHETER TO PREVENT ADHERENCE OF THE CATHETER TIP AND TO ENSURE THAT NO UNPOLYMERIZED MIXTURE WILL LEAK DURING CATHETER WITHDRAWAL. IF THE MICROCATHETER TIP BECOMES GLUED TO THE VASCULAR SITE, IT MAY BE NECESSARY TO CONSIDER SURGICAL INTERVENTION.¿ IN THIS CASE, THE PHYSICIAN ¿WAITED A FEW MORE SECONDS BEFORE PULLING THE CATHETER¿ AFTER NOTING GLUE REFLUX BEHIND THE CATHETER, WHICH RESULTED IN DISLODGING THE GLUE CAST AND A CEREBRAL HEMORRHAGE. SINCE THE EVENT NECESSITATED A SURGICAL INTERVENTION (I.E., BALLOON DILATION AND COILING) TO PRECLUDE FURTHER PATIENT COMPLICATIONS, THIS EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ 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 FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT USED THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / LOT#: UNKNOWN) TO EMBOLIZE A SMALL / LONG ARTERIOVENOUS FISTULA (AVF) FROM THE SUPERIOR CEREBELLAR ARTERY (SCA), THE PHYSICIAN WANTED TO FORM A SMALL PLUG USING THE TRUFILL AT THE ORIGIN OF THE FISTULA. THERE WAS A SMALL BRANCH JUST PROXIMAL TO THE ORIGIN OF THE FISTULA THAT THE PHYSICIAN DID NOT WANT TO OCCLUDE. USING A NEURON MAX® ACCESS SHEATH (PENUMBRA), HEADWAY® DUO MICROCATHETER (TERUMO NEURO), AND A SYNCHRO® GUIDEWIRE (STRYKER) HE WAS ABLE TO NAVIGATE TO THE TARGET SITE. THE TRUFILL WAS PREPPED IN A 1:1 RATIO, NBCA TO ETHIODIZED OIL. THE HEADWAY DUO MICROCATHETER WAS PREPPED WITH 3CC OF DEXTROSE 5% IN WATER (D5W). THE TRUFILL INJECTION SYRINGE WAS A 1CC MEDALLION® SYRINGE (MERIT MEDICAL). THE FIRST INJECTION FORMED A SMALL PLUG / CAST AT THE TARGET SITE AND THE MICROCATHETER WAS SAFELY REMOVED WHILE ASPIRATING ON THE 1CC SYRINGE. AFTER A CONTRAST INJECTION SHOW FLOW WAS STILL IN THE AVF, THE PHYSICIAN ELECTED FOR A SECOND INJECTION. HE WAS ABLE TO GET A SECOND MICROCATHETER, AN EXCELSIOR SL-10® MICROCATHETER (STRYKER) TO THE TARGET SITE AND SLIGHTLY WEDGED IN THE CAST OF THE FIRST TRUFILL INJECTION. THE PHYSICIAN PREPPED THE MICROCATHETER WITH 3CC OF D5W AND THEN USED ANOTHER 1CC MEDALLION SYRINGE TO INJECT THE 1:1 TRUFILL SOLUTION. ¿AFTER A FEW SECONDS OF INJECTING, WE STARTED TO SEE REFLUX BEHIND THE CATHETER AND INTO THE SMALLER VESSEL JUST PROXIMAL TO THE TARGET SITE. THE PHYSICIAN WAITED A FEW MORE SECONDS BEFORE PULLING THE CATHETER.¿ IT WAS REPORTED THAT UPON THE FIRST PULL, THE PHYSICIAN NOTICED THAT IT WAS NOT MOVING. HE AGREED TO PUT A SMALL TENSION ON THE CATHETER TO SLOWLY RELEASE THE TIP. WHEN THIS TECHNIQUE DID NOT WORK, THE PHYSICIAN ¿THEN PULLED WITH MORE FORCE. THIS CAUSED THE TRUFILL CAST TO DISLODGE AND CAUSED THE SCA TO START TO BLEED. A BALLOON WAS THEN PLACED IN THE BASILAR ARTERY TO ARREST THE FLOW INTO THE SCA. COILS WERE THEN USED TO STOP THE BLEEDING AT THE SCA ORIGIN / BASILAR ARTERY. ON 28-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE MOST CURRENT STATUS OF THE PATIENT IS UNKNOWN, HOWEVER, ¿GIVEN THE SEVERITY OF THE BLEED, THERE WOULD BE ADDITIONAL SYMPTOMS. THE VESSEL LOOKED TO BE TORN, AND THE BLEED WAS SEVERE. 10-12 NANO COILS (STRYKER) WERE USED TO STOP THE BLEED AT THE SCA. THE PATIENT¿S HOSPITALIZATION WAS PROLONGED, BUT THE DURATION WAS NOT KNOWN. RELATED TO THE CHARACTERISTICS OF THE TARGET SITE, THE INFORMATION INDICATED THE FOLLOWING: ¿CATHETER WAS IN LINE TO THE PEDICLE WHEN INJECTED. RATHER STRAIGHT SCA AND PEDICLE, WITH MODERATE FLOW RATE. AS MENTIONED IN ORIGINAL DESCRIPTION, THERE WAS A SMALL VESSEL JUST PROXIMAL TO TARGET SITE THAT THE PHYSICIAN WAS TRYING TO AVOID.¿ THERE WERE NO DISCREPANCIES OR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. THE LOT NUMBER OF THE TRUFILL N-BCA USED WAS NOT RECOVERED SINCE IT WAS NOT A MALFUNCTION OR A COMPLAINT DIRECTLY AGAINST THE DEVICE, THE ADVERSE EVENT WAS DUE TO [A] TECHNICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296522 TRUFILL TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CERENOVUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L EXCELSIOR SL-10® MICROCATHETER (STRYKER).| HEADWAY® DUO MICROCATHETER (TERUMO NEURO).| MEDALLION® SYRINGE (MERIT MEDICAL).| NEURON MAX® ACCESS SHEATH (PENUMBRA).| SYNCHRO® GUIDEWIRE (STRYKER).