BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25033114 · Received April 29, 2026

    Report

    Report Number
    3008114965-2026-00617
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 24, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075288
    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

    IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, DURING A STENT ANGIOPLASTY FOR VASCULAR STENOSIS, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENCR402300, LOT NUMBER: 9854671) WAS IMPEDED IN THE MIDDLE SECTION OF A COMPETITOR¿S MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN Y CONNECTOR. THE DOCTOR REMOVED THE Y CONNECTOR AND REMOVED THE STENT AND THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. 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 ¿YES¿. 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, AND THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE Y CONNECTOR¿. THE REPLACEMENT STENT WAS AN ENTERPRISE2 OF THE SAME PRODUCT CODE. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-APR-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE. THERE WERE NO OTHER DEVICES SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE TARGET VESSEL WAS THE LEFT MIDDLE CEREBRAL ARTERY. THERE WAS ¿MODERATE TORTUOSITY¿ AT THE VESSEL. A GUIDEWIRE IN THE MICROCATHETER WAS USED PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42256 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9854671 10886704075288

    Patients

    Seq Age Sex Outcome Treatment
    1