BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22787763 · Received August 12, 2025

    Report

    Report Number
    3008114965-2025-00812
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 3, 2025
    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). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 23MM ENTERPRISE 2 WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGE WAS OBSERVED. A FUNCTIONAL TEST WAS PERFORMED. A LAB SAMPLE PROWLER SELECT PLUS MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE. THE RETURNED DEVICE WAS THEN INSERTED INTO THE MICROCATHETER, AND IT ADVANCED SMOOTHLY WITHOUT ANY RESISTANCE OR FRICTION AS THE STENT PASSED THROUGH. THE STENT WAS SUCCESSFULLY EXPELLED FROM THE DISTAL TIP OF THE MICROCATHETER. THE FUNCTIONAL TEST WAS PERFORMED WITHOUT ISSUES; THE REPORTED IMPEDED CONDITION ENCOUNTERED DURING THE PROCEDURE COULD NOT BE CONFIRMED. HOWEVER, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061889. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTION FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: THE INTRODUCER MUST BE PROPERLY ENGAGED WITH THE INFUSION CATHETER HUB TO ENABLE STENT INTRODUCTION INTO THE INFUSION CATHETER. 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, 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.

    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 27-AUG-2025. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. 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 9061889. 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 (AND/OR PART 4, AS APPLICABLE).. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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 A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), THE 4MM X 23MM ENTERPRISE 2 (ENCR402312 / 9061889) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT # UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 06-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS STILL ON THE DELIVERY WIRE. THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER 4MM X 23MM ENTERPRISE 2 (ENCR402312) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). PER THE INFORMATION, THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350398 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061889 10886704075271

    Patients

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