BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24037111 · Received January 12, 2026

    Report

    Report Number
    3008114965-2026-00125
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 10, 2026
    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, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A 4.5X22MM STENT ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452212, LOT NUMBER: 9061886) COULD NOT BE ADVANCED FURTHER, PROMPTING THE PHYSICIAN TO REMOVE BOTH THE STENT AND UNSPECIFIED MICROCATHETER (MC) FROM THE PATIENT AND SWITCHING TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A SURGERY PROLONGATION OF APPROXIMATELY 10 MINUTES, BUT THERE WERE NO REPORTED PATIENT CONSEQUENCES OR ADVERSE OUTCOMES. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JAN-2026 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A MICROVENTION TAIERMAO MICROCATHETER 21. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURE PROLONGATION/DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE EU 4.5X22MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT WAS ALREADY DETACHED FROM THE DELIVERY SYSTEM. THE DISTAL END OF THE DELIVERY WIRE WAS KINKED. 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. 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 DAMAGED CONDITIONS FOUND ON THE DISTAL END OF THE DELIVERY WIRE. IT IS SUGGESTED THAT EXCESSIVE FORCE COULD HAD BEEN INADVERTENTLY APPLIED DURING THE SEVERAL ATTEMPTS TO ADVANCE THE STENT THROUGH THE MICROCATHETER, RESULTING IN THE KINKED CONDITION OF THE DELIVERY WIRE. 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 DETACHMENT WAS NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THIS IS NOT CONSIDERED TO THE ISSUE REPORTED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATED TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 9061886. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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 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: ¿ 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.

    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. 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 ANGIOPLASTY PROCEDURE, A 4.5X22MM STENT ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452212, LOT NUMBER: 9061886) COULD NOT BE ADVANCED FURTHER, PROMPTING THE PHYSICIAN TO REMOVE BOTH THE STENT AND UNSPECIFIED MICROCATHETER (MC) FROM THE PATIENT AND SWITCHING TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A SURGERY PROLONGATION OF APPROXIMATELY 10 MINUTES, BUT THERE WERE NO REPORTED PATIENT CONSEQUENCES OR ADVERSE OUTCOMES. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JAN-2026 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A MICROVENTION TAIERMAO MICROCATHETER 21. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURE PROLONGATION/DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268850 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061886 10886704043980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MICROVENTION TAIERMAO MICROCATHETER 21.