BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22288578 · Received June 18, 2025

    Report

    Report Number
    3008114965-2025-00546
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704071471
    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. (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. 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 9020399. 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 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.

    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 08-JUL-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). 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 4.5 MM X 22 MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. AS REPORTED IN THE COMPLAINT EVENT DESCRIPTION, THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY SYSTEM. THE INTRODUCER WAS NOT RETURNED FOR EVALUATION. THE STENT COMPONENT WAS FOUND DETACHED INSIDE THE CONCOMITANT MICROCATHETER; HOWEVER, IT COULD NOT BE RETRIEVED WITHOUT DAMAGING BOTH THE STENT AND MICROCATHETER. MICROSCOPIC INSPECTION REVEALED A FRACTURE BETWEEN THE CONCENTRIC LOOPS OF THE PROXIMAL POSITIONING COIL AND THE CORE WIRE; HOWEVER, THE DISTAL END OF THE DELIVERY WIRE UNDERWENT DIMENSIONAL ANALYSIS, AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS, INCLUDING THOSE SPECIFICATIONS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT. THEREFORE, DEVICE FAILURE IS NOT SUSPECTED TO BE A CONTRIBUTING FACTOR. ALTHOUGH IN ORDER TO PERFORM A FUNCTIONAL TEST, THE STENT MUST BE ATTACHED TO THE DELIVERY WIRE AND INSIDE THE INTRODUCER, THE ISSUE REPORTED REGARDING THE STENT BEING IMPEDED IS CONFIRMED BASED ON THE DAMAGES FOUND ON THE PROXIMAL END OF THE DELIVERY WIRE. IT IS SUGGESTED THAT EXCESSIVE FORCE COULD HAD BEEN INADVERTENTLY APPLIED DURING THE ATTEMPTS TO ADVANCE THE STENT THROUGH THE MICROCATHETER'S HUB, RESULTING IN THE DAMAGES OF THE DELIVERY WIRE AND DETACHED CONDITION OF THE STENT. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND OPERATOR'S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AT THIS TIME, THERE IS NO EVIDENCE TO SUPPORT THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9020399. 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. 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: B4, G3, G6, H2, H3, H6, AND H11. 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 POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY, WITH NO OBVIOUS TORTUOSITY OF THE BLOOD VESSEL, THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 9020399) WAS IMPEDED IN THE PROXIMAL END OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY WITH NO OBVIOUS VESSEL TORTUOSITY. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. PER THE ADDITIONAL INFORMATION, WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS NO LONGER ON THE DELIVERY WIRE. THE STENT WAS STILL INSIDE THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE AND NO NEGATIVE IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685912 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9020399 10886704071471

    Patients

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