BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKENTERPRISE2

    MDR report key: 19319932 · Received May 15, 2024

    Report

    Report Number
    3008114965-2024-00492
    Event Type
    Death
    Date Received
    May 15, 2024
    Date of Event
    August 12, 2023
    Report Date
    May 15, 2024
    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

    PRODUCT COMPLAINT #: (B)(4). 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. H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS 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 FOR STENT THROMBOSIS: ALTHOUGH NO SPECIFIC INTERVENTION IS STATED, IT IS CLINICALLY REASONABLE TO ASSUME AN INTERVENTION WOULD BE PROVIDED IN THE CASE OF A OCCLUSION AT/NEAR THE STENT SITE. THE TYPE OF OCCLUSION IS NOT SPECIFIED AND BEING CODED AS A CEREBRAL THROMBOSIS. THE EVENT IS BEING REPORTED TO THE US FDA AS A CONSERVATIVE MEASURE, UNDER THE CLASSIFICATION OF "SERIOUS INJURY." CLINICIAN ASSESSMENT FOR SYMPTOMATIC HEMORRHAGE: 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 UNDER THE CLASSIFICATION OF "SERIOUS INJURY." CLINICIAN ASSESSMENT FOR SYMPTOMATIC HEMORRHAGE RESULTING IN DEATH: THE CORRELATING RELATIONSHIP BETWEEN THE EVENT OF "SYMPTOMATIC HEMORRHAGE RESULTING IN DEATH" TO THE USED DEVICE/PROCEDURE, CANNOT BE RULED OUT ENTIRELY. THE EVENT IS BEING REPORTED TO THE US FDA AS A CONSERVATIVE MEASURE, UNDER THE CLASSIFICATION OF "DEATH." THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: XI Z, GUANGXIN D, HE Z, ZHIBIN C, YUN L, TINGZHENG Z, YUN X, JINGWEI L. SAFETY AND EFFECTIVENESS ASSESSMENT OF ENDOVASCULAR RECANALIZATION FOR NON-ACUTE MIDDLE CEREBRAL ARTERY OCCLUSION. CNS NEUROSCI THER. 2024 MAR;30(3):E14426. DOI: 10.1111/CNS.14426. EPUB 2023 AUG 29. PMID: 37641873; PMCID: PMC10915976. BACKGROUND AND PURPOSE: WE AIM TO EVALUATE THE EFFECTIVENESS AND SAFETY OF ENDOVASCULAR RECANALIZATION FOR PATIENTS WITH SYMPTOMATIC NONACUTE MIDDLE CEREBRAL ARTERY OCCLUSION. METHODS: NINETY-EIGHT PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC NONACUTE MIDDLE CEREBRAL ARTERY OCCLUSION WERE DIVIDED INTO DRUG TREATMENT GROUPS (42) AND ENDOVASCULAR TREATMENT GROUPS (56). THE RATE OF RECANALIZATION, PERI-PROCEDURAL COMPLICATIONS, AND FOLLOW-UP RESULTS WERE EVALUATED. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: QTY UNK: ENTERPRISE STENTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH THE ENTERPRISE2: QTY 1: STENT THROMBOSIS. QTY 2: SYMPTOMATIC HEMORRHAGE, ONE OF WHICH RESULTED IN DEATH. TREATMENTS WERE NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273990 UNKENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D