BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23693372 · Received December 2, 2025

    Report

    Report Number
    3008114965-2025-01333
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043973
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    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. THE COMPLAINT WAS SUBMITTED WITH PROCEDURAL IMAGING, WHICH IS PENDING FURTHER ANALYSIS. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED AND THE REPORTED FAILURE COULD NOT BE EVALUATED. 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. THE INCOMPLETE EXPANSION OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VDR) CAN POTENTIALLY LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. SINCE THE ALLEGED DEVICE DEFICIENCY REQUIRED ADDITIONAL INTERVENTION IN AN EFFORT TO FULLY EXPAND THE STENT AND PRECLUDE PATIENT HARM, THE EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY,¿ WITH AN AWARENESS DATE OF 20-NOV-2025. 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 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. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). THE MEDICAL IMAGING WAS REVIEWED BY (B)(6), ON (B)(6) 2025. THE ASSESSMENT READS AS FOLLOWS: ¿THE DESCRIPTION IS CLEAR. THE IMAGE SHOWS THAT THE PROXIMAL MARKERS OF THE STENT (IN THIS ROADMAP CAPTURE) ARE STILL CLOSE TO EACH OTHER. THERE ARE A NUMBER OF POSSIBLE REASONS FOR THIS OCCURRENCE BESIDES A MANUFACTURING PROBLEM. IF THE VESSEL IS SPASTIC IN THE PROXIMAL PORTION, WHICH CANNOT BE ASSESSED ON A ROADMAP IMAGE, THE STENT MAY NOT OPEN. ALSO, IF THERE IS BLOOD REFLUXING IN THE MICROCATHETER UPON DEPLOYMENT OF THE STENT, THE DEVICE MAY NOT OPEN DUE TO CLOT CONSTRAINING THE OPENING. OFTEN THE STENT WILL OPEN UPON MANIPULATION WITH THE WIRE AND MICROCATHETER, BUT GIVEN THAT THIS IS THE ONLY IMAGE AVAILABLE, IT IS UNCLEAR IF THIS WAS PERFORMED.¿ A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EU 4.5X14MM STENT 12 MM DW TIP (ENC451412/ 8962456) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION OF THE ENTERPRISE2. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿INCOMPLETE EXPANSION. IT WAS REPORTED THAT DURING PROCEDURE, STENT WAS ADVANCED TO TARGET POSITION AND RELEASED, IT WAS FOUND THAT DISTAL MARKERS WERE OPENED WELL, BUT PARTIAL PROXIMAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED COMPLETELY AS INTENDED. DOCTOR COMPLETED THE SURGERY.¿ NO PATIENT HARM OR PROCEDURAL DELAY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-NOV-2025. SUMMARY: THE TEMPERATURE-INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. VESSEL OR ANEURYSM FACTORS WERE NOT IDENTIFIED AS CONTRIBUTORS TO THE INCOMPLETE EXPANSION. ADDITIONAL INTERVENTIONS WERE PERFORMED IN AN ATTEMPT TO EXPAND THE STENT. ALTHOUGH INCOMPLETE EXPANSION OCCURRED, IT DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION. NO BLOOD FLOW RESTRICTION WAS OBSERVED. THE PROCEDURE WAS DELAYED/PROLONGED BECAUSE OF THE EVENT, BUT THIS PROLONGATION DID NOT CAUSE ANY PATIENT ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958348 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8962456 10886704043973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention