BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25283734 · Received May 26, 2026

    Report

    Report Number
    3008114965-2026-00732
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075271
    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 REF# (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION H3 - 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. 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

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENCR402312, LOT NUMBER: 9924776) WAS IMPEDED IN THE TIP SECTION OF THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE (THE DELIVERY WIRE OF THE STENT PASSED THROUGH THE MICROCATHETER). THE DOCTOR ONLY RETRACTED THE STENT ALONE, THE STENT COULD NOT BE RETRACTED BACK TO THE INTRODUCER. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. DOES SURGEON HAVE AN EXTRA SET OF HANDS TO SUPPORT WHILE FLUSHING ALIGNING THE ENTERPRISE SYSTEM WAS ANSWERED AS ¿YES¿. IS A PUSH PLUNGE RHV BEING USED WAS ANSWERED AS ¿TWISTED TYPE¿. IS THERE FORCE NEEDED TO REMOVE THE DELIVERY WIRE ONCE IMPEDED AND THEN THE STENT DETACHES IN THE HUB OR THE PROXIMAL END OF THE MICROCATHETER WAS ANSWERED AS ¿YES, THE DOCTOR INCREASED FORCE TO REMOVE THE DELIVERY WIRE¿. THE STENT WAS STILL ATTACHED TO THE DELIVERY WIRE. THE REPLACEMENT STENT WAS ANOTHER ENTERPRISE2 OF SAME PRODUCT CODE. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-MAY-2026 INDICATED THAT A GUIDEWIRE IN THE MICROCATHETER WAS USED PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THEY WERE ABLE TO TORQUE THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THE 10 MINIUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86385 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9924776 10886704075271

    Patients

    Seq Age Sex Outcome Treatment
    1