BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 21961429 · Received May 5, 2025

    Report

    Report Number
    3008114965-2025-00369
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 12, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075271
    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). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER EMAIL ADDRESS WAS 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 9061791. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STENT -PREMATURE DETACHMENT AND IMPEDIMENT IN MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE. LOSS OF TARGET POSITION IN THE CEREBRAL VASCULATURE (VERTEBRAL OR INTERNAL CAROTID AND ANY OF THEIR BRANCHES) WILL REQUIRE RE-ACCESSING THE TARGET SITE WITH INCREASED POTENTIAL FOR VESSEL TRAUMA/VASOSPASM/ISCHEMIA DUE TO CEREBRAL VASOSPASM. IF THE STENT WERE TO PREMATURELY DETACH WHILE IN THE PATIENT (IN AN UNINTENDED SITE), IT MAY LEAD TO DAMAGE OF HEALTHY INTIMA, POSSIBLE SIDE BRANCH OCCLUSION, ISCHEMIA, INFARCT AND/OR THE NEED FOR ADDITIONAL INTERVENTION. THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING CLOT BURDEN, VESSEL CHARACTERISTICS (I.E., TORTUOSITY), AND MECHANICAL MANIPULATION OF DEVICES THAT MAY HAVE CONTRIBUTED TO THE EVENTS RATHER THAN A DEVICE DESIGN OR MANUFACTURING ISSUE. IN THIS CASE, THERE WERE NO REPORTS OF PATIENT INJURY; THEREFORE, THIS EVENT DOES NOT MEET US FDA REPORTING CRITERIA AS A SERIOUS INJURY. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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 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. 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. 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 4MM X 23MM ENTERPRISE 2 WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY UNIT AND RETURNED INSIDE OF A Y-CONNECTOR. THE STENT WAS REMOVED WITHOUT ANY DIFFICULTY. 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). THE STENT WAS FULLY EXPANDED, AND BOTH ENDS WERE NOTED TO BE COMPLETELY FLARED. THE DELIVERY WIRE UNDERWENT DIMENSIONAL ANALYSIS, AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS, INCLUDING THOSE SPECIFICATIONS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT. THEREFORE, DEVICE FAILURE IS NOT SUSPECTED TO BE A CONTRIBUTING FACTOR. THE REPORTED ISSUE IN THE COMPLAINT REGARDING THE STENT BEING PREMATURELY DETACHED WAS CONFIRMED AS THE STENT COMPONENT WAS RETURNED ALREADY DETACHED FROM THE DELIVERY UNIT. BASED ON THE DETACHED CONDITION OF THE STENT, THE REPORTED ISSUE OF THE STENT BEING IMPEDED IN THE PROXIMAL END OF THE 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 PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061791. 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. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTION FOR USE (IFU) DOES 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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.

    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 09-JUN-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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 23MM ENTERPRISE 2 (ENCR402312 / 9061791) WAS IMPEDED IN THE PROXIMAL END OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED THE DEVICES TO COMPLETE THE PROCEDURE, WHICH WAS REPORTEDLY PROLONGED BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 28-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGETED ANEURYSM WAS LOCATED ON THE ¿POSTERIOR COMMUNICATING SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY.¿ AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ASIDE FROM THE STENT BEING PREMATURELY DETACHED, THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM WHEN IT WAS REMOVED. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPLACEMENT STENT WAS ANOTHER 4MM X 23MM ENTERPRISE 2 (ENCR402312) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT, HOWEVER, THE PHYSICIAN ¿FELT THAT PROLONGING BY 10 MINUTES WAS CLINICALLY SIGNIFICANT BECAUSE IT INCREASED THE FREQUENCY OF THE PROCEDURE AND POSED MORE RISKS TO THE PROCEDURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475571 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061791 10886704075271

    Patients

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