BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25202548 · Received May 18, 2026

    Report

    Report Number
    3008114965-2026-00716
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075301
    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 E1. INITIAL REPORTER PHONE: (B)(6). 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO USE, THE PHYSICIAN OPENED THE DEVICE PACKAGING OF AN ENTERPRISE2 4MMX30MM NO TIP (PRODUCT CODE: ENCR403000, LOT NUMBER: 9924743) AND REMOVED THE DEVICE FROM THE DISPENSER HOOP. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT BESIDES THE REPORTED PREMATURE DETACHMENT, THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM. ANOTHER ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE WAS USED. THE EVENT DID NOT EVENT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23983 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9924743 10886704075301

    Patients

    Seq Age Sex Outcome Treatment
    1