BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25003958 · Received April 27, 2026

    Report

    Report Number
    3008114965-2026-00601
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043980
    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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. IMPEDED IN MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION IS A KNOWN POTENTIAL COMPLICATION OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD). LOSS OF TARGET POSITION IN THE INTRACRANIAL VASCULATURE (WITH THE EXCEPTION OF THE INTERNAL CAROTID ARTERY) WILL REQUIRE RE-ACCESSING THE TARGET SITE WITH INCREASED POTENTIAL FOR VESSEL TRAUMA, VESSEL SPASM, OR ISCHEMIA/INFARCT. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. ¿ IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UNSHEATHE THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. 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. 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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452212, LOT NUMBER: 9872895) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. 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 ¿NOT APPLICABLE¿. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE DURING ITS DELIVERY IN THE MICROCATHETER. THE REPLACEMENT STENT WAS AN ENTERPRISE1 OF THE SAME PRODUCT CODE. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-APR-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. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106189 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9872895 10886704043980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown