BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 17280475 · Received July 7, 2023

    Report

    Report Number
    3008114965-2023-00468
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    April 1, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: TANG K, ZHANG C, LIU X, ZHAO L, WANG X, LIU X, MA S, GAO C, GAO S, ZHANG G, HU Y, WU J. ENDOVASCULAR TREATMENT STRATEGIES AND A NEW CLASSIFICATION FOR MULTIPLE ANEURYSMS OF THE IPSILATERAL OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. ASIAN J SURG. 2023 APR 1:S1015-9584(23)00439-6. DOI: 10.1016/J.ASJSUR.2023.03.134. EPUB AHEAD OF PRINT. PMID: 37012159. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS. THE EVENT IS REPORTABLE TO THE US FDA. 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. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: TANG K, ZHANG C, LIU X, ZHAO L, WANG X, LIU X, MA S, GAO C, GAO S, ZHANG G, HU Y, WU J. ENDOVASCULAR TREATMENT STRATEGIES AND A NEW CLASSIFICATION FOR MULTIPLE ANEURYSMS OF THE IPSILATERAL OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. ASIAN J SURG. 2023 APR 1:S1015-9584(23)00439-6. DOI: 10.1016/J.ASJSUR.2023.03.134. EPUB AHEAD OF PRINT. PMID: 37012159. PURPOSE/OBJECTIVE/METHODS: OBJECTIVE: ANEURYSMS OCCURRING IN THE OPHTHALMIC SEGMENT (C6) OF THE INTERNAL CAROTID ARTERY (ICA) HAVE COMPLEX ANATOMY. THIS POSES A CHALLENGE FOR THE USE OF TRADITIONAL OPEN SURGERY, WHICH IS GRADUALLY BEING REPLACED BY ENDOVASCULAR TREATMENT (EVT). HOWEVER, MULTIPLE ANEURYSM (MA) EVT, ESPECIALLY IN MAS OCCURRING IPSILATERALLY, HAS NOT BEEN SPECIFICALLY DESCRIBED OR DISCUSSED. THE PRESENT STUDY AIMED TO PROPOSE A MORE CONCISE CLINICAL CLASSIFICATION STANDARD FOR IPSILATERAL C6 ICA MAS AND REPORT ON THE CLINICAL EXPERIENCE WITH EVT. METHODS: THE CASES OF 18 PATIENTS WITH IPSILATERAL C6 ICA MAS TREATED WITH EVT WERE RETROSPECTIVELY REVIEWED. THE TREATMENT RESULTS AND PROCEDURE-RELATED COMPLICATIONS WERE RECORDED, AND CLINICAL AND ANGIOGRAPHIC FOLLOW-UPS WERE PERFORMED AT LEAST SIX MONTHS AFTER SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: (LVIS STENT (MICROVENTION); TUBRIDGE VASCULAR RECONSTRUCTION DEVICE (TUBRIDGE). THE ARTICLE DOES NOT IDENTIFIY DEVICE MANUFACTURER OF THE COILS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH AN UNIDENTIFIED ENTERPRISE STENT: CASE #18 TREATED WITH STENT AND COILS EXPERIENCED PROCEDURAL COMPLICATION OF A STROKE TREATED WITH AN INTRAVENOUS TIROFIBAN INJECTION AND DISCHARGED WITHOUT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421480 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening