BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24831597 · Received April 9, 2026

    Report

    Report Number
    3008114965-2026-00491
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075271
    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: (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. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO INCLUDED IN THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTO INCLUDED IN THE COMPLAINT SHOWS ONLY A DETACHED STENT. THE STENT WAS OBSERVED TO BE IN GOOD CONDITION. THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS). IT WAS ALSO NOTED TO BE FULLY EXPANDED WITH BOTH ENDS COMPLETELY FLARED. NO OTHER DAMAGE WAS OBSERVED. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT REGARDING THE STENT BEING IMPEDED IN THE MICROCATHETER CANNOT BE EVALUATED BASED ON THE PHOTO PROVIDED. HOWEVER, THE ISSUE REPORTED REGARDING THE STENT BEING SEPARATED PREMATURELY FROM THE DELIVERY WIRE WAS CONFIRMED BASED ON THE DETACHED CONDITION OF THE STENT AS CAPTURED IN THE PHOTO. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9854672. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4) THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 05-MAY-2026. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.11. 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 4MM X 23MM ENTERPRISE 2 (ENCR402312 / 9854672) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE ASSOCIATED MICROCATHETER. THE PHYSICIAN RETRACTED THE STENT, AND THE STENT COMPONENT WAS FOUND PREMATURELY DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE PHYSICIAN REPLACED THE STENT TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING ARTERY. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ASIDE FROM THE REPORTED PREMATURE DETACHMENT OF THE STENT COMPONENT, THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (ENCR401612). THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52851 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9854672 10886704075271

    Patients

    Seq Age Sex Outcome Treatment
    1