BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 22093068 · Received May 27, 2025

    Report

    Report Number
    3008114965-2025-00445
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 27, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043980
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    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 AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8872358. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THE INCOMPLETE EXPANSION OF THE ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE CAN POTENTIALLY LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE ALLEGED DEVICE DEFICIENCY REQUIRED AN ADDITIONAL INTERVENTION (I.E., USE OF A DELIVERY WIRE TO MASSAGE THE STENT) IN AN EFFORT TO FULLY EXPAND THE STENT. ADDITIONALLY, THE STENT WAS IMPLANTED WITHOUT FULL EXPANSION. IT APPEARS THE PATIENT WAS PLACED ON ANTICOAGULATION THERAPY TO MITIGATE THE RISK OF THROMBUS FORMATION. PER THE ADDITIONAL INFORMATION RECEIVED ON 22-MAY-2025, IT WAS CLARIFIED THAT THE PATIENT INITIALLY PRESENTED WITH A RIGHT VERTEBRAL ARTERY OCCLUSION, FOR WHICH THE ANTIPLATELET MEDICATION WAS GIVEN. THE EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY¿ BASED ON THE ADDITIONAL SURGICAL INTERVENTION (I.E., USE OF A DELIVERY WIRE TO MASSAGE THE STENT) AS AN ATTEMPT TO FULLY EXPAND THE STENT. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. 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. 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. 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 EVENT WAS REPORTED VIA THE CHINA HEALTH AUTHORITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SUBARACHNOID HEMORRHAGE (SAH) AND WAS DIAGNOSED WITH A RUPTURED RIGHT VERTEBRAL ARTERY ANEURYSM WITH SAH. ON (B)(6) 2025, THE PATIENT UNDERWENT A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE IN THE EMERGENCY DEPARTMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL MARKERS OF THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 8872358) CONVERGED AND AS A RESULT, THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE STENT WAS RELEASED, AND THE PHYSICIAN USED THE DELIVERY WIRE TO ¿MASSAGE¿ THE MARKERS, BUT THE MARKERS WERE STILL UNABLE TO OPEN. THE STENT WAS IMPLANTED, AND THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 15 MINUTES. PER THE TRANSLATED HEALTH AUTHORITY REPORT, THE PATIENT HAD PRE-OPERATIVE VASCULAR PATENCY. ¿THE ENTERPRISE STENT IS A SELF-EXPANDING STENT. CONSIDERING THAT THE STENT DID NOT EXPAND WELL, THE DISTAL END COULD NOT BE OPENED. RIGHT VERTEBRAL ARTERY OCCLUSION WAS PERFORMED; TIROFIBAN WAS GIVEN FOR ANTIPLATELET THERAPY AFTER [THE] OPERATION, NIMODIPINE WAS USED TO RELIEVE CEREBRAL VASOSPASM, MANNITOL DEHYDRATION WAS GIVEN TO REDUCE CEREBRAL EDEMA AND INTRACRANIAL PRESSURE, AND SYMPTOMATIC SUPPORTIVE TREATMENT WAS GIVEN.¿ ON 22-MAY-2025, LIMITED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE FOLLOWING SEQUENCE OF EVENT: ¿THE PATIENT PRESENTED TO THE HOSPITAL WITH A SUBARACHNOID HEMORRHAGE AND WAS DIAGNOSED WITH A RUPTURED RIGHT VERTEBRAL ARTERY ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THE PATIENT UNDERWENT STENT-ASSISTED ANEURYSM EMBOLIZATION IN THE EMERGENCY DEPARTMENT. THE ENTERPRISE STENT WAS USED, AND THE DISTAL END OF THE STENT DID NOT OPEN FULLY, AND THE RIGHT VERTEBRAL ARTERY WAS OCCLUDED.¿ THERE WERE NO VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THE TEMPERATURE INDICATOR ON THE INNER POUCH WAS CHECKED AND CONFIRMED TO BE WITHIN ACCEPTABLE CRITERIA. THE PHYSICIAN DID NOT CONSIDER THE 15-MINUTE PROCEDURE EXTENSION TO BE CLINICALLY SIGNIFICANT DUE TO THE PATIENT¿S ORIGINAL PRESENTATION. THE PATIENT¿S HOSPITALIZATION WAS NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728655 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8872358 10886704043980

    Patients

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