BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24313743 · Received February 11, 2026

    Report

    Report Number
    3008114965-2026-00284
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043973
    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 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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X14MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC451412, LOT NUMBER: 8962456) BECAME IMPEDED AT THE PROXIMAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: UNKNOWN) AND WAS UNABLE TO ADVANCE. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, AND THE STENT WAS NOTED TO HAVE PREMATURELY DETACHED FROM THE DELIVERY WIRE WHILE INSIDE THE MICROCATHETER (MC). THE PHYSICIAN SUBSEQUENTLY REMOVED THE MICROCATHETER AND THE DETACHED STENT FROM THE PATIENT. A NEW SET OF DEVICES WAS USED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR ADDITIONAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-FEB-2026 INDICATED THAT A GUIDEWIRE WAS USED IN THE MICROCATHETER PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THEY WERE NOT 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 NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE EU 4.5X14MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT WAS DETACHED IN THE ASSOCIATED MICROCATHETER'S HUB. 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. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT REGARDING A STENT BEING AUTOMATICALLY RELEASED 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 ASSOCIATED MICROCATHETER CANNOT BE EVALUATED THROUGH FUNCTIONAL TESTING. THE STENT MUST BE INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. ADDITIONALLY, THE RETURNED COMPONENTS DID NOT 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. 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. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X14MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC451412, LOT NUMBER: 8962456) BECAME IMPEDED AT THE PROXIMAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: UNKNOWN) AND WAS UNABLE TO ADVANCE. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, AND THE STENT WAS NOTED TO HAVE PREMATURELY DETACHED FROM THE DELIVERY WIRE WHILE INSIDE THE MICROCATHETER (MC). THE PHYSICIAN SUBSEQUENTLY REMOVED THE MICROCATHETER AND THE DETACHED STENT FROM THE PATIENT. A NEW SET OF DEVICES WAS USED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR ADDITIONAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-FEB-2026 INDICATED THAT A GUIDEWIRE WAS USED IN THE MICROCATHETER PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THEY WERE NOT 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 NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246263 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8962456 10886704043973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown