BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23490750 · Received November 6, 2025

    Report

    Report Number
    3008114965-2025-01196
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 6, 2025
    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. 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. 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. 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, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9061882) WAS ADVANCED TO TARGET POSITION AND STARTED TO RELEASE. DURING THE PROCESS OF RELEASING THE STENT, IT WAS FOUND THAT DISTAL MARKERS COULD NOT BE OPENED COMPLETELY. THE DOCTOR ONLY RETRACTED THE STENT ALONE, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-OCT-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. IT IS UNKNOWN IF THERE WERE ANY 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 PROLONGATION/DELAY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702568 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061882 10886704075288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown