BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23051130 · Received September 15, 2025

    Report

    Report Number
    3008114965-2025-00980
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075387
    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 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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403000, 9020409) WAS IMPEDED IN INTRODUCER, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED AND THE REPORTED FAILURE COULD NOT BE EVALUATED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATED TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 9020409. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORDS EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. 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, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403000, 9020409) WAS IMPEDED IN INTRODUCER, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND ONLY THE DELIVERY WIRE WAS RETURNED FOR EVALUATION. MICROSCOPIC INSPECTION REVEALED THAT THE PROXIMAL END OF THE PROXIMAL COIL WAS SEVERELY STRETCHED. DIMENSIONAL ANALYSIS ON THOSE SPECIFICATIONS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT WERE FOUND WITHIN SPECIFICATIONS. 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 ISSUE REPORTED REGARDING THE STENT BEING PREMATURELY DETACHED IS CONFIRMED, AND ALTHOUGH IN ORDER TO PERFORM A FUNCTIONAL TEST FOR IMPEDED CONDITIONS THE STENT MUST BE ATTACHED TO THE DELIVERY WIRE AND INSIDE THE INTRODUCER, THE IMPEDED CONDITION IS CONFIRMED BASED ON THE DAMAGES OF THE DELIVERY WIRE. THIS DAMAGE SUGGEST THAT EXCESSIVE PUSH/PULL FORCE MAY HAVE BEEN INADVERTENTLY APPLIED RESULTING IN A DETACHED STENT AND DAMAGED DELIVERY WIRE; HOWEVER, THIS REMAINS SPECULATIVE. 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. THE STENT AND INTRODUCER COMPONENTS MIGHT HAVE GOTTEN LOST DURING THE RETURN PROCESS. IF THESE DEVICES ARE RECEIVED AT A LATER TIME, THIS INVESTIGATION WILL BE READDRESS ACCORDINGLY. AS PART OF 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. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. 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, D9, G3, G6, H2, H3 AND H11. 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, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403000, 9020409) WAS IMPEDED IN INTRODUCER, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518258 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9020409 10886704075387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown