BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22774524 · Received August 11, 2025

    Report

    Report Number
    3008114965-2025-00866
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075394
    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). COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM VASCULAR RECONSTRUCTION DEVICE (ENCR403912, 9080740) WAS IMPEDED IN THE DISTAL END A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31527352) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE STENT; THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-AUG-2025 INDICATED THAT THEY WERE 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. THERE WAS PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT, HOWEVER, IT DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE ENTERPRISE2 4MMX39MM VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND AS DESCRIBED IN THE EVENT, THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY SYSTEM. THE DISTAL END OF THE DELIVERY WIRE WAS SEVERELY KINKED AND COVERED IN RESIDUES. MICROSCOPIC INSPECTION WAS PERFORMED ON THE STENT COMPONENT. IT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. THE DELIVERY WIRE WAS SUBJECTED TO DIMENSIONAL ANALYSIS AND THOSE SPECIFICATIONS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT WERE FOUND WITHIN SPECIFICATIONS. THEREFORE, DEVICE FAILURE IS NOT SUSPECTED TO BE A CONTRIBUTING FACTOR. 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. ALTHOUGH THE DETACHED CONDITION OF THE STENT PREVENTED PROPER FUNCTIONAL TESTING FOR THE IMPEDED CONDITION REPORTED, THE COMPLAINT IS CONFIRMED BASED ON THE DAMAGE OF THE DELIVERY WIRE. IT IS SUGGESTED THAT EXCESSIVE FORCE COULD HAD BEEN INADVERTENTLY APPLIED DURING THE ATTEMPTS TO ADVANCE THE STENT THROUGH THE DAMAGED CONCOMITANT MICROCATHETER, RESULTING IN THE KINKED CONDITIONS OF THE DELIVERY WIRE. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED; HOWEVER, 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. 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 CAPA 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. 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, G3, G6, H2, AND H11. SECTION B5; ADDITIONAL EVENT INFORMATION RECEIVED ON 14-AUG-2025 INDICATED THAT THEY WERE 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. THERE WAS PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT, HOWEVER, IT 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). 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. 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 (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 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, AN ENTERPRISE2 4MMX39MM VASCULAR RECONSTRUCTION DEVICE (ENCR403912, 9080740) WAS IMPEDED IN THE DISTAL END A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31527352) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034673 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9080740 10886704075394

    Patients

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