BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 25260931 · Received May 22, 2026

    Report

    Report Number
    3008114965-2026-00717
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704044000
    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. NO: (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 IS NOT AVAILABLE / REPORTED. 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 9924739. 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. 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 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453712 / 9924739) WAS IMPEDED IN THE MIDDLE SECTION OF THE ASSOCIATED 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31691231) AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN RETRACTED ONLY THE STENT; THE STENT COMPONENT WAS STILL ON THE DELIVERY WIRE WHEN IT WAS REMOVED. THE PHYSICIAN REPLACED IT WITH A 4.5MM X 14MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE NO DISTAL TIP (ENC451400 / 9599742), BUT THE SECOND STENT ALSO HAD THE SAME ISSUE. THE PHYSICIAN ATTEMPTED TO RETRACT THE SECOND STENT, BUT THE STENT COMPONENT WAS FOUND PREMATURELY DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE Y-CONNECTOR. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT AND REPLACED THE MICROCATHETER WITH ANOTHER FROM A DIFFERENT MANUFACTURER AND REPLACED THE STENT WITH ANOTHER 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453712) TO COMPLETE THE PROCEDURE, WHICH WAS PROLONGED BY ABOUT 20 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 18-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C5 SEGMENT OF THE OPHTHALMIC ARTERY. CONTINUOUS FLUSH WAS MAINTAINED. PER THE INFORMATION, THERE WAS DAMAGE ON THE FIRST STENT, BUT THE TYPE OF DAMAGE WAS NOT PROVIDED. THE SECOND STENT, ASIDE FROM THE REPORTED PREMATURE DETACHMENT, WAS FRACTURED. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND THE PHYSICIAN DID NOT CONSIDER THE REPORTED 20-MINUTE PROCEDURE EXTENSION TO BE CLINICALLY SIGNIFICANT. BASED ON THE INFORMATION RECEIVED ON 18-MAY-2026, THE FIRST STENT WAS DAMAGE; THE ISSUE HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39675 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9924739 10886704044000

    Patients

    Seq Age Sex Outcome Treatment
    1