BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 20787250 · Received November 26, 2024

    Report

    Report Number
    3008114965-2024-01093
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 10, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704071471
    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 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. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO INCLUDED IN THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTO SHOWS THE OUTER AND INNER PACKAGING OF AN ENTERPRISE DEVICE AND IT CAN BE OBSERVED TO BE TORN. A CUT MICROCATHETER CAN BE SEEN, AND A DISPENSER HOOP CAN BE SEEN TOO; HOWEVER, NO ENTERPRISE COMPONENTS (DELIVERY WIRE, INTRODUCER, STENT) CAN BE SEEN. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061784. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE ISSUE REPORTED REGARDING THE STENT BECOMING IMPEDED AND PREMATURELY SEPARATED CANNOT BE EVALUATED SINCE NO ENTERPRISE COMPONENTS ARE SHOWN IN THE PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. 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 THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 23-DEC-2024. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. 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 PROXIMAL END OF A NON-CERENOVUS MICROCATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED, AND A PROXIMAL END OF A DELIVERY WIRE WAS OBSERVED PROTRUDING FROM THE MICROCATHETER HUB. THE REMAINDER OF THE DELIVER WIRE WAS REMOVED, AND THE STENT COMPONENT OF THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS FOUND. 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 AND NO KINKS). IT WAS ALSO OBSERVED TO BE FULLY EXPANDED WITH BOTH ENDS COMPLETELY FLARED. THE ISSUES REPORTED ARE CONFIRMED BASED ON THE BROKEN DELIVERY WIRE. THE BROKEN CONDITION OF THE DELIVERY WIRE SUGGEST THAT THE DELIVERY WIRE WAS PUSHED OR RETRACTED AGAINST RESISTANCE SUFFICIENTLY TO CAUSE THE DELIVERY WIRE TO BREAK AND RELEASE THE STENT INSIDE OF THE MICROCATHETER. THERE IS NO INDICATION 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 9061784. 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 INSTRUCTIONS FOR USE (IFU) DOES 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. 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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 9061784) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) AND COULD NOT PASS THROUGH. IT WAS REPORTED THAT AT THE SAME TIME, THE STENT WAS AUTOMATICALLY RELEASED; THE STENT BODY WAS PREMATURELY SEPARATED FROM THE DELIVERY WIRE. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT. THE STENT WAS RELEASED, AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT STENT AND THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. ON 25-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANEURYSM AT THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA). CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878517 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9061784 10886704071471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MICROCATHETER (UNSPECIFIED BRAND)