BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23464375 · Received November 4, 2025

    Report

    Report Number
    3008114965-2025-01185
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 3, 2025
    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 REF#(B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, AND H11. SECTION B5: ADDITIONAL EVENT INFORMATION RECEIVED ON 24-NOV-2025 INDICATED THAT 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. THE 10 MINUTES PROCEDURE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. 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, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8872359) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-NOV-2025 INDICATED THAT 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. THE 10 MINUTES PROCEDURE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE DISTAL END OF THE DELIVERY WIRE WAS SEPARATED. THE DISTAL END OF THE DELIVERY WIRE WAS FOUND STUCK WITH THE STENT IN THE INTRODUCER. NO ADDITIONAL DAMAGE WAS FOUND UNDER MAGNIFICATION. 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 BROKEN CONDITION OF THE DELIVERY WIRE SUGGEST THAT THE DELIVERY WIRE WAS PUSHED OR RETRACTED AGAINST RESISTANCE SUFFICIENTLY TO CAUSE THE DELIVERY WIRE TO BREAK. THEREFORE, THE CUSTOMER COMPLAINT CAN BE CONFIRMED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF 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. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT PARTIALLY DEPLOY THE STENT FROM THE INTRODUCER. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. CONFIRM THE TIP OF THE DELIVERY WIRE IS ENTIRELY WITHIN THE INTRODUCER. 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). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. 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. 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 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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8872359) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212077 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8872359 10886704043980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROWLER SELECT PLUS 150/5CM.