BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24903893 · Received April 16, 2026

    Report

    Report Number
    3008114965-2026-00540
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 5, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043997
    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. 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 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452812, LOT NUMBER: 9924737) WAS IMPEDED IN MICROCATHETER HUB OF A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X, LOT NUMBER: 31674220) AND COULD NOT BE PUSHED INTO THE MICROCATHETER (MC). THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2023 INDICATED THAT A GUIDEWIRE WAS USED IN THE MICROCATHETER PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS A PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT, HOWEVER, IT DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80629 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9924737 10886704043997

    Patients

    Seq Age Sex Outcome Treatment
    1