BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23498863 · Received November 7, 2025

    Report

    Report Number
    3008114965-2025-01201
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 17, 2025
    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. TWO PHOTOS WERE ATTACHED TO THE COMPLAINT FILE. IN SUCH PHOTOS IT WAS NOTED THAT THE DELIVERY WIRE IS BROKEN IN TWO SEPARATE PARTS PROXIMALLY TO THE STENT WHICH REMAINS INSIDE THE MICROCATHETER. NO OTHER DAMAGE WAS OBSERVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 9080734. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO INTERNAL ACTION ACTIVITY IS REQUIRED. THE ISSUE REGARDING THE STENT BEING IMPEDED IN THE INTRODUCER AND THE DELIVERY WIRE SEPARATION WAS CONFIRMED BASED ON THE BROKEN CONDITION OF THE DELIVERY WIRE. 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9080734) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC). THE DOCTOR TRIED TO RETRACT THE STENT AND OBSERVED THE DELIVERY WIRE OF THE STENT HAD FRACTURED/SEPARATED. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-NOV-2025 INDICATED THAT THE MICROCATHETER USED WAS A PROWLER SELECT PLUS. THE STENT FRACTURE/SEPTATION DID NOT OCCUR INSIDE THE PATIENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO PROCEDURE DELAYED/PROLONGED DUE TO THE EVENT. TWO PHOTOS WERE ATTACHED TO THE COMPLAINT FILE. IN SUCH PHOTOS IT WAS NOTED THAT THE DELIVERY WIRE IS BROKEN IN TWO SEPARATE PARTS PROXIMALLY TO THE STENT WHICH REMAINS INSIDE THE MICROCATHETER. NO OTHER DAMAGE WAS OBSERVED. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT AND DISTAL END OF PROXIMAL COIL WERE FOUND SEPARATED FROM THE REST OF THE DELIVERY WIRE AND DETACHED AT THE PROXIMAL END OF THE INTRODUCER. NO ADDITIONAL DAMAGES WERE FOUND DURING MICROSCOPIC INSPECTION. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE FINDINGS MENTIONED ABOVE. IT IS SUGGESTED THAT AN ADEQUATE FLUSH WAS NOT MAINTAINED, WHICH CAN RESULT IN AN INCREASE IN FRICTION WHEN MANEUVERING THE DELIVERY SYSTEM. IN AN ATTEMPT TO OVERCOME THIS ADDED RESISTANCE, EXCESSIVE FORCE MAY HAVE BEEN UNINTENTIONALLY APPLIED, LEADING TO MECHANICAL STRESS ON THE DELIVERY WIRE AND ULTIMATELY RESULTING IN ITS BREAKAGE. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THERE IS NO INDICATION THAT THE ISSUES REPORTED IN THE COMPLAINT RESULT FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. AS PART OF THE J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO INTERNAL ACTION ACTIVITY IS REQUIRED AT THIS TIME. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UNSHEATHE THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#(B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, D9, G3, G6, H2, H3 AND H11. SECTION B5: ADDITIONAL EVENT INFORMATION RECEIVED ON 11-NOV-2025 INDICATED THAT THE MICROCATHETER USED WAS A PROWLER SELECT PLUS. THE STENT FRACTURE/SEPTATION DID NOT OCCUR INSIDE THE PATIENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO PROCEDURE DELAYED/PROLONGED DUE TO THE EVENT. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9080734) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC). THE DOCTOR TRIED TO RETRACT THE STENT AND OBSERVED THE DELIVERY WIRE OF THE STENT HAD FRACTURED/SEPARATED. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861948 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9080734 10886704043997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED MICROCATHETER