BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25319264 · Received May 28, 2026

    Report

    Report Number
    3008114965-2026-00757
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 17, 2026
    Report Date
    May 28, 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. 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. INCOMPLETE STENT EXPANSION IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE 2 VRD. WITH THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE ASSOCIATED DEVICES, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. HOWEVER, THE EVENT MAY HAVE BEEN RELATED TO A COMBINATION OF MULTIPLE FACTORS EXPERIENCED IN THE CLINICAL SETTING RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT PARTIALLY DEPLOY THE STENT FROM THE INTRODUCER. ¿ MAINTAIN ADEQUATE STENT LENGTH (APPROXIMATELY 5 MM) ON EACH SIDE OF THE ANEURYSM NECK TO ENSURE APPROPRIATE NECK COVERAGE. ¿ SELECT A STENT LENGTH THAT IS AT LEAST 10 MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5 MM ON EITHER SIDE OF THE ANEURYSM NECK. A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL MAY INCREASE THE RISK OF STENT MIGRATION. 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 HEALTH CARE PROFESSIONAL REPORTED THAT DURING ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENCR402312, LOT NUMBER: 9926002) WAS ADVANCED TO TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT 3 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED COMPLETELY AS INTENDED. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-MAY-2026 INDICATED THAT 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 ENTERPRISE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WAS NO PROCEDURE DELAYED/PROLONGED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326908 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9926002 10886704075271

    Patients

    Seq Age Sex Outcome Treatment
    1