BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 24083251 · Received January 15, 2026

    Report

    Report Number
    3008114965-2026-00164
    Event Type
    Death
    Date Received
    January 15, 2026
    Report Date
    January 15, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.2: DATE OF DEATH: THE DATE OF DEATH WAS NOT REPORTED. SECTION B.3: DATE OF EVENT: THE DATE OF THE EVENT WAS NOT REPORTED / KNOWN. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE ARE NOT AVAILABLE. SECTION E.1: THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE PATIENT PRESENTED WITH SEVERE UNDERLYING CEREBROVASCULAR DISEASE, INCLUDING NON-TRAUMATIC ANEURYSMAL SUBARACHNOID HEMORRHAGE AND VASOSPASM, WHICH ARE INDEPENDENTLY ASSOCIATED WITH A HIGH RISK OF ISCHEMIC INJURY, CEREBRAL EDEMA, AND MORTALITY. DURING ENDOVASCULAR TREATMENT, THE DEPLOYED INTRACRANIAL STENT EXPERIENCED GRADUAL LUMINAL COMPROMISE REQUIRING RE-INTERVENTION AND SUBSEQUENT REMOVAL. ALTHOUGH THE PATIENT¿S CLINICAL DETERIORATION AND DEATH ARE LIKELY MULTIFACTORIAL AND INFLUENCED BY SIGNIFICANT PRE-EXISTING PATHOLOGY AND DISEASE PROGRESSION, A TEMPORAL ASSOCIATION EXISTS BETWEEN THE STENT OCCLUSION, SUBSEQUENT ISCHEMIA, AND THE FATAL OUTCOME. THEREFORE, WHILE A DEFINITIVE CAUSAL RELATIONSHIP CANNOT BE ESTABLISHED, THE DEVICE CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR TO THE ADVERSE EVENT. THE EVENT IS REPORTABLE TO THE US FDA UNDER THE CLASSIFICATION OF ¿DEATH.¿ 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 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: MCGRATH K, HEY G, MACNEIL A, WAHBEH T, LUCKE-WOLD B, CHOWDHURY MAB, AMINI S, KOCH M, CHALOUHI N, HOH B. FUNCTIONAL OUTCOMES FOLLOWING ENDOVASCULAR TREATMENT OF VASOSPASM SECONDARY TO ANEURYSMAL SUBARACHNOID HEMORRHAGE: A SINGLE CENTER RETROSPECTIVE ANALYSIS. J CLIN NEUROSCI. 2025 MAY;135:111205. DOI: 10.1016/J.JOCN.2025.111205. EPUB 2025 MAR 26. PMID: 40147068. BACKGROUND AND PURPOSE: ENDOVASCULAR TREATMENT OF POST-HEMORRHAGIC CEREBRAL VASOSPASM (PHCV) HAS THE POTENTIAL TO IMPROVE FUNCTIONAL OUTCOMES BUT THERE CONTINUES TO BE LIMITED DATA REPORTED IN THE LITERATURE. TO RETROSPECTIVELY REVIEW OUR INSTITUTION'S EXPERIENCE TREATING PHCV ENDOVASCULARLY AND REPORT CLINICAL OUTCOME DATA. METHODS: PATIENTS WHO EXPERIENCED NONTRAUMATIC SUBARACHNOID HEMORRHAGE (SAH) AND WERE TREATED WITH ENDOVASCULAR THERAPY WERE IDENTIFIED USING ICD AND CPT CODES. DEMOGRAPHIC, CLINICAL, AND OUTCOME VARIABLES WERE THEN COLLECTED VIA REVIEW OF ELECTRONIC MEDICAL RECORDS. THE PRIMARY OUTCOME MEASURE WAS RATE OF MODIFIED RANKIN SCORE (MRS) = 2 AT DISCHARGE AS WELL AS 1, 3, AND 6 MONTHS AFTER DISCHARGE. DISCHARGE DISPOSITION, ANGIOGRAPHIC RESPONSE TO TREATMENT, AND COMPLICATION RATES WERE SECONDARY OUTCOMES. A SUBGROUP ANALYSIS WAS PERFORMED ON PATIENTS TREATED WITH RETRIEVABLE STENTS. CONCLUSIONS: OUR EXPERIENCE WITH ENDOVASCULAR TREATMENT OF PHCV RESULTS IN SIMILAR FUNCTIONAL OUTCOMES AND COMPLICATION RATES TO THE LITERATURE. BETTER PRESENTING GCS PREDICTS GOOD FUNCTIONAL OUTCOMES IN PATIENTS WITH PHCV TREATED ENDOVASCULARLY. PATIENTS UNDERGOING MECHANICAL ANGIOPLASTY TENDED TO BE YOUNGER. RETRIEVABLE STENTS PRODUCED SIMILAR RATES OF COMPLICATIONS AND GOOD FUNCTIONAL OUTCOMES TO BALLOON ANGIOPLASTY PATIENTS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNKENTERPRISE2 DEVICE(S): -A PATIENT HAD GRADUAL OCCLUSION ACROSS THE DEPLOYED STENT, PROMPTING TREATMENT WITH STENT-TRIEVER AGAIN, REMOVAL OF THE PREVIOUSLY DEPLOYED ENTERPRISE, AND ABCIXIMAB. THE MCA REMAINED PATENT OVER THE FOLLOWING MINUTES, BUT LATER THAT DAY HE EXPERIENCED A DECLINE IN HIS NEUROLOGIC EXAM. CTA AT THAT TIME REVEALED ISCHEMIA IN THE RIGHT ACA AND MCA TERRITORIES, SIGNIFICANT EDEMA IN THE RIGHT CEREBRAL HEMISPHERE, AND 1.2 CM OF MIDLINE SHIFT WITH UNCAL AND SUBFALCINE HERNIATION. DESPITE MAXIMAL MEDICAL MANAGEMENT AND DECOMPRESSIVE HEMICRANIECTOMY, HE CONTINUED TO HAVE REFRACTORY INTRACRANIAL HYPERTENSION, AND HIS FAMILY ELECTED TO PROCEED WITH ORGAN DONATION A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141912 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death