BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22787948 · Received August 12, 2025

    Report

    Report Number
    3008114965-2025-00815
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075257
    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¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 27-AUG-2025. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.3: 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT: 9080736. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE EMPTY INNER POUCH OF A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. NO OTHER ENTERPRISE COMPONENT WAS RETURNED FOR EVALUATION. NO FURTHER INVESTIGATION IS BEING CONDUCTED WITHOUT THE DEVICE. THIS INVESTIGATION IS CONSIDERED COMPLETE AT THIS TIME; IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED AT A LATER TIME, THIS INVESTIGATION WILL BE UPDATED, AND FURTHER ACTIONS CAN BE TAKEN AS NEEDED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9080736. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 9584137) WAS IMPEDED IN THE HUB OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31492232) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED ONLY THE STENT, BUT THE STENT COMPONENT WAS OBSERVED TO BE PREMATURELY DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE Y-CONNECTOR. THE PHYSICIAN REPLACED IT WITH A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401612 / 9080736), BUT THIS SECOND STENT WAS ALSO IMPEDED IN THE MICROCATHETER HUB AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT FROM THE PATIENT AND REPLACED BOTH DEVICES WITH DEVICES FROM OTHER MANUFACTURERS AND COMPLETED THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 06-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE POSTERIOR COMMUNICATING ARTERY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. PER THE INFORMATION, REGARDING THE FIRST STENT (ENC452212), IT WAS NOT KNOWN IF WHEN IT WAS REMOVED, WHETHER IT WAS STILL ON THE DELIVERY WIRE. THE SECOND STENT (ENCR401612) WAS STILL ON THE DELIVERY WIRE WHEN IT WAS REMOVED. IT WAS NOT KNOWN IF THE STENTS / STENT DELIVERY SYSTEMS FOR BOTH STENTS APPEARED DAMAGE WHEN THE SYSTEMS WERE REMOVED. IT WAS NOT KNOWN IF THERE WAS ANY DAMAGE NOTED ON THE MICROCATHETER. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350430 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9080736 10886704075257

    Patients

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