BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 20951597 · Received December 17, 2024

    Report

    Report Number
    3008114965-2024-01247
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 3, 2024
    Report Date
    January 27, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    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

    PRODUCT COMPLAINT # (B)(4) UPDATED SECTIONS ON THIS MED WATCH REPORT: B4, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9020399) BECAME IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31338517) AND COULD NOT ADVANCE ANY MORE. AT THE SAME TIME THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-DEC-2024 INDICATING THAT THEY WERE 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 WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. A NON-STERILE EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND AS DESCRIBED IN THE EVENT, THE STENT WAS DETACHED FROM THE DELIVERY SYSTEM. NO APPEARANCE OF DAMAGES WAS NOTED. 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 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. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE ISSUE REPORTED REGARDING THE STENT BECOMING IMPEDED CANNOT BE EVALUATED DUE TO THE DETACHED CONDITION OF THE STENT. IN ORDER TO PERFORM A FUNCTIONAL TEST, THE STENT MUST BE ATTACHED TO THE DELIVERY WIRE AND INSIDE THE INTRODUCER; HOWEVER, BASED ON THIS CONDITION, THE ISSUE REPORTED REGARDING THE STENT BEING RELEASED IS CONFIRMED. THE DIMENSIONAL ANALYSIS PERFORMED SHOWED NO ISSUES THAT COULD HAVE RESULTED IN THE PREMATURE DETACHMENT OF THE STENT. WITH THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE FAILURE ENCOUNTERED CANNOT BE DETERMINED. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THERE IS NO INDICATION THAT THE ISSUES REPORTED IN THE COMPLAINT RESULT FROM A DEFECT INHERENTLY RELATED TO THE ENTERPRISE DEVICE. AS PART OF THE J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: CAREFULLY PLACE THE DISPENSER HOOP INTO THE STERILE FIELD. REMOVE THE DELIVERY WIRE FROM THE CLIP ON THE DISPENSER HOOP. GRASP THE PROXIMAL END OF THE INTRODUCER AND THE DELIVERY WIRE AT THE POINT WHERE IT EXITS THE INTRODUCER. HOLD WIRE AND INTRODUCER TOGETHER TO PREVENT STENT MOVEMENT. REMOVE THE CERENOVUS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM FROM THE DISPENSER HOOP. DO NOT PARTIALLY DEPLOY THE STENT FROM THE INTRODUCER. CONFIRM THAT THE DELIVERY WIRE DOES NOT MOVE RELATIVE TO THE INTRODUCER DURING THE REMOVAL OF THE CERENOVUS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM FROM THE DISPENSER HOOP. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). SECTION B5: ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-DEC-2024 INDICATING THAT THEY WERE 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 WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (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. 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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 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

    AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9020399) BECAME IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31338517) AND COULD NOT ADVANCE ANY MORE. AT THE SAME TIME THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486162 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9020399

    Patients

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