BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22002879 · Received May 12, 2025

    Report

    Report Number
    3008114965-2025-00429
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704044024
    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. 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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, H6 AND H11. ONE PHOTO ACCOMPANIED THE COMPLAINT FILE. IN SAID PHOTO, A STENT COMPONENT CAN BE SEEN INSIDE AN INTRODUCER AND ATTACHED TO THE DELIVERY WIRE; HOWEVER, THE DELIVERY WIRE SEEMS BROKEN NEXT TO THE RETRACTION BUMP, SEPARATING THE DISTAL END OF THE DELIVERY WIRE AND THE STENT COMPONENT FROM THE REST OF THE DELIVERY SYSTEM. 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 CUSTOMER COMPLAINT WAS CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF 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 CAPA ACTIVITY IS REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H11. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8945940) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. DOCTOR ONLY RETRACTED THE STENT ALONE, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE DOCTOR SWITCHED A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAY-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION. ONE PHOTO ACCOMPANIED THE COMPLAINT FILE. IN SAID PHOTO, A STENT COMPONENT CAN BE SEEN INSIDE AN INTRODUCER AND ATTACHED TO THE DELIVERY WIRE; HOWEVER, THE DELIVERY WIRE SEEMS BROKEN NEXT TO THE RETRACTION BUMP, SEPARATING THE DISTAL END OF THE DELIVERY WIRE AND THE STENT COMPONENT FROM THE REST OF THE DELIVERY SYSTEM. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY SYSTEM INSIDE OF THE INTRODUCER. THE DISTAL END OF THE DELIVERY WIRE WAS BROKEN NEXT TO THE RETRACTING BUMP. THESE CONDITIONS ARE CONSISTENT WITH THE DAMAGES SEEN ON THE PROVIDED PICTURE. 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 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 DISENGAGE THE STENT INSIDE THE INTRODUCER. THEREFORE, THE CUSTOMER COMPLAINT CAN BE CONFIRMED. 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 DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 8945940. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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 CAPA ACTIVITY 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: 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. 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

    AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8945940) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. DOCTOR ONLY RETRACTED THE STENT ALONE; THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE DOCTOR SWITCHED A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAY-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016885 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8945940 10886704044024

    Patients

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