BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23927526 · Received December 30, 2025

    Report

    Report Number
    3008114965-2025-01482
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 14, 2025
    Report Date
    February 9, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704044000
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT MULTIPLE ATTEMPTS TO OBTAIN PRODUCT FOR ANALYSIS WERE UNSUCCESSFUL. IF THE PRODUCT IS RETURNED OR INFORMATION PROVIDED AT A LATER DATE, THE FILE WILL BE UPDATED ACCORDINGLY. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. (B)(4) PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061787. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.11. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, RACE, AND ETHNICITY WAS NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. SECTION H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT: 9061787. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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 TARGETING A RUPTURED ANEURYSM, THE 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453712 / 9061787) WAS DELIVERED TO THE TARGET SITE AND THE DELIVERY WIRE PASSED THROUGH THE TIP OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND), BUT THE PHYSICIAN WAS UNABLE TO VISUALIZE THE STENT UNDER IMAGING. THE PHYSICIAN RETRACTED ONLY THE STENT AND NOTED THAT THE STENT COMPONENT WAS PREMATURELY DETACHED FROM THE DELIVERY WIRE; THE STENT COMPONENT WAS IN THE INTRODUCER, IT COULD NOT BE CONFIRMED WHEN THE STENT BECAME SEPARATED FROM THE DELIVERY WIRE. THE PHYSICIAN REPLACED THE STENT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 29-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS A RUPTURED ANEURYSM ON THE C6 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. ASIDE FROM THE REPORTED PREMATURE DETACHMENT OF THE STENT, THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453712). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220517 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061787 10886704044000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female