BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23726392 · Received December 5, 2025

    Report

    Report Number
    3008114965-2025-01377
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 30, 2025
    Report Date
    January 14, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043997
    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, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MMD ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9242468) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31586954) AND COULD NOT ADVANCE ANY MORE. THEY ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED A SECOND NEW STENT, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452812, LOT NUMBER: 9616877), BUT THIS SECOND STENT WAS ALSO IMPEDED IN THE MIDDLE SECTION OF THE ORIGINAL MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE SECOND STENT, THE SECOND STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE ORIGINAL MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE ORIGINAL MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A SECOND NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X, LOT NUMBER: 31626342). A THIRD STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9924736) ALSO IMPEDED IN THE MIDDLE SECTION OF THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE THIRD STENT FROM THE PATIENT AND SWITCHED OUT TO NEW DEVICES (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE IMPACT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-DEC-2025 INDICATED THAT THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THERE WERE NO VESSELS OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT WAS DETACHED FROM THE DELIVERY UNIT; THIS WAS NOT RETURNED FOR EVALUATION. THE DELIVERY WIRE AND THE INTRODUCER WERE RETURNED IN GOOD CONDITION. THE DELIVERY WIRE WAS SUBJECTED TO DIMENSIONAL ANALYSIS, AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATION, INCLUDING THOSE SPECIFICATIONS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT. THEREFORE, DEVICE FAILURE IS NOT SUSPECTED TO BE A CONTRIBUTING FACTOR. THE CUSTOMER COMPLAINT REGARDING A STENT BEING DETACHED WAS CONFIRMED SINCE THE STENT WAS NOTED AS ALREADY SEPARATED FROM THE DELIVERY SYSTEM; BASED ON THIS CONDITION, THE ISSUE REGARDING A STENT BEING IMPEDED IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER CANNOT BE EVALUATED THROUGH FUNCTIONAL TESTING. THE STENT MUST BE INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. ADDITIONALLY, NONE OF THE RETURNED COMPONENTS PRESENT DAMAGES THAT SUGGEST THAT THEY WERE FORCIBLY ADVANCED. 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. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 9616877. 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: 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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) 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. 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 ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MMD ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9242468) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31586954) AND COULD NOT ADVANCE ANY MORE. THEY ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED A SECOND NEW STENT, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452812, LOT NUMBER: 9616877), BUT THIS SECOND STENT WAS ALSO IMPEDED IN THE MIDDLE SECTION OF THE ORIGINAL MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE SECOND STENT, THE SECOND STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE ORIGINAL MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE ORIGINAL MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A SECOND NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X, LOT NUMBER: 31626342). A THIRD STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452800, LOT NUMBER: 9924736) ALSO IMPEDED IN THE MIDDLE SECTION OF THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE THIRD STENT FROM THE PATIENT AND SWITCHED OUT TO NEW DEVICES (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE IMPACT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED. THE COMPLAINT DEVICES ARE AVAILABLE FOR RETURN AND FURTHER ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-DEC-2025 INDICATED THAT THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THERE WERE NO VESSELS OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867843 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9616877 10886704043997

    Patients

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