BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24931456 · Received April 20, 2026

    Report

    Report Number
    3008114965-2026-00534
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043980
    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¿S REF. (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). SECTION H.3: 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9872895. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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. 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 MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE (ENC452212 / 9872895) WAS IMPEDED IN THE DISTAL END OF THE ASSOCIATED 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31663264) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE STENT AND REPLACED IT WITH A 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452812 / 9872897). THE SECOND STENT ENCOUNTERED THE SAME ISSUE AS THE FIRST STENT. THE PHYSICIAN REMOVED THE STENT AND THEN REMOVED THE MICROCATHETER FROM THE PATIENT; THE PHYSICIAN REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT BOTH STENTS WERE REMOVED WITHOUT ISSUE, THE STENT COMPONENTS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY WIRES. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452812). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 15-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE STENTS / STENT DELIVERY SYSTEMS. THERE WAS ALSO NO DAMAGE NOTED ON THE MICROCATHETER WHEN IT WAS REMOVED. THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE RESULTED FROM THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88770 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9872895 10886704043980

    Patients

    Seq Age Sex Outcome Treatment
    1