BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKENTERPRISE2

    MDR report key: 24040446 · Received January 12, 2026

    Report

    Report Number
    3008114965-2026-00132
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    September 4, 2025
    Report Date
    January 12, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    Adverse Event
    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). SECTION D4: UDI: AS THE CATALOG/MODEL NUMBERS WERE NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. SECTION E.1: THE INITIAL REPORTER CONTACT INFORMATION IS NOT AVAILABLE. SECTION H.4: THE DEVICE MANUFACTURE DATES ARE NOT KNOWN AS THE DEVICE LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. CLINICIAN ASSESSMENT: THIS STUDY REPORTS 9 CASES OF ANEURYSM RECANALIZATION AFTER STENT-ASSISTED COILING TREATMENT. TREATMENTS WERE NOT MENTIONED; THE SEVERITY OF THE EVENTS IS UNKNOWN. SINCE THE EVENT IS LIFE THREATENING AND MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR REQUIRED SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS. THE EVENTS ARE REPORTABLE TO THE US FDA. THE COMPLAINT WILL BE UPDATED WITH ANY ADDITIONAL INFORMATION RECEIVED FROM PERFORMING FOLLOW-UP ACTIVITY WITH THE CORRESPONDING AUTHOR, AND REPORTABILITY FOR THE US FDA WILL BE REASSESSED. 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 INTERNAL 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 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG QY, RUAN XL, CHEN R, SHI ZS. CIRCUMFERENTIAL ANEURYSM WALL ENHANCEMENT PREDICTS RECANALIZATION AFTER STENT-ASSISTED COILING IN SMALL UNRUPTURED INTRACRANIAL ANEURYSMS. BRAIN BEHAV. 2025 SEP;15(9):E70898. DOI: 10.1002/BRB3.70898. PMID: 40977123; PMCID: PMC12451054. BACKGROUND: CIRCUMFERENTIAL ANEURYSM WALL ENHANCEMENT (CAWE) ON HIGH-RESOLUTION VESSEL WALL IMAGING (HR-VWI) AS A VESSEL WALL INFLAMMATION MARKER IS ASSOCIATED WITH UNRUPTURED INTRACRANIAL ANEURYSMS (UIAS) INSTABILITY AND RECANALIZATION AFTER ENDOVASCULAR TREATMENT. THIS STUDY EVALUATES THE ASSOCIATION OF CAWE WITH RECANALIZATION OF SMALL UIAS (< 10 MM) TREATED WITH STENT-ASSISTED COILING (SAC) OR COILING ALONE AND AIMS TO DEVELOP A PREDICTION MODEL FOR RECANALIZATION BASED ON CAWE. OBJECTIVE: THIS STUDY AIMED TO INVESTIGATE THE ASSOCIATION BETWEEN CAWE AND QUANTITATIVELY MEASURED ANEURYSM WALL ENHANCEMENT IN 3T HRVWI WITH RECANALIZATION OF SMALL UIAS (< 10 MM) TREATED WITH COILING WITH OR WITHOUT STENT ASSISTANCE, MAINLY FOCUSING ON SAC, AS WELL AS TO DEVELOP A PREDICTION MODEL FOR RECANALIZATION BASED ON CAWE. METHODS: WE ANALYZED PATIENTS WITH SMALL SACCULAR UIAS UNDERGOING 3T HR-VWI AND TREATED WITH SAC OR COILING ALONE BETWEEN OCTOBER 2018 AND MAY 2024. A FOUR-GRADE SCALE ASSESSED ANEURYSM WALL ENHANCEMENT (NONE, FOCAL THICK WALL ENHANCEMENT, THIN CAWE, AND THICK CAWE). THE ANEURYSM-TO-PITUITARY STALK CONTRAST RATIO (CRSTALK) QUANTIFIED ENHANCEMENT. WE INVESTIGATED THE RELATIONSHIP BETWEEN CAWE AND RECANALIZATION AND DEVELOPED A RECANALIZATION PREDICTION MODEL. CONCLUSIONS: CAWE ON HR-VWI IS A SIGNIFICANT IMAGING MARKER FOR PREDICTING RECANALIZATION IN SMALL UIAS UNDERGOING SAC. THE PROPOSED RECANALIZATION RISK SCALE NEEDS VALIDATION IN LARGER STUDIES. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CNV DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING AN ENTERPRISE 2 STENTS (CODMAN NEURO) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNKENTERPRISE2 DEVICE(S): QTY 14: ANEURYSM RECANALIZATION. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97275 UNKENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening