BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13014222 · Received December 15, 2021

    Report

    Report Number
    3008114965-2021-00679
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    July 17, 2017
    Report Date
    December 15, 2021
    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

    (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG Y, HUANG QH, FANG Y, YANG P, XU Y, HONG B, LIU J. A NOVEL FLOW DIVERTER (TUBRIDGE) FOR THE TREATMENT OF RECURRENT ANEURYSMS: A SINGLE-CENTER EXPERIENCE. KOREAN J RADIOL. 2017 SEP-OCT;18(5):852-859. DOI: 10.3348/KJR.2017.18.5.852. EPUB 2017 JUL 17. PMID: 28860903; PMCID: PMC5552469. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. (B)(6).: 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. THERE IS NO INDICATION THAT THE ENTERPRISE STENTS MALFUNCTIONED OR THAT THE EVENTS ARE RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG Y, HUANG QH, FANG Y, YANG P, XU Y, HONG B, LIU J. A NOVEL FLOW DIVERTER (TUBRIDGE) FOR THE TREATMENT OF RECURRENT ANEURYSMS: A SINGLE-CENTER EXPERIENCE. KOREAN J RADIOL. 2017 SEP-OCT;18(5):852-859. DOI: 10.3348/KJR.2017.18.5.852. EPUB 2017 JUL 17. PMID: 28860903; PMCID: PMC5552469. OBJECTIVE AND METHODS: THIS ARTICLE REPORTS A SINGLE INSTITUTION'S INITIAL EXPERIENCE IN THE REPAIR OF ANEURYSM RECURRENCE WITH THE TUBRIDGE FLOW DIVERTER (FD). A DATABASE WAS REVIEWED PROSPECTIVELY, AND 8 PATIENTS WITH 8 RECURRENT ANEURYSMS WERE IDENTIFIED. FOUR ANEURYSMS HAD PREVIOUSLY RUPTURED. THE PREVIOUS ANEURYSM TREATMENT CONSISTED OF COILING IN 1 ANEURYSM AND SINGLE-STENT-ASSISTED COILING IN 7 ANEURYSMS. AMONG THE STENTS MOST COMMONLY USED ALONE WERE LEO (BALT) (N = 3), ENTERPRISE (N = 2), NEUROFORM (BOSTON SCIENTIFIC) (N =1), AND SOLITAIRE (EV3) (N = 1). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT (QUANTITY OF 2) OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: LEO (BALT) (N = 3), ENTERPRISE (N = 2), NEUROFORM (BOSTON SCIENTIFIC) (N =1), AND SOLITAIRE (EV3) (N = 1), TUBRIDGE FD (MICROPORT MEDICAL COMPANY) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: TWO PATIENTS WITH ENTERPRISE STENTS DEVELOPED ANEURYSM RECURRENCE, AND SUBSEQUENTLY UNDERWENT PLACEMENT OF THE TUBRIDGE FLOW DIVERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905683 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention LEO (BALT)| NEUROFORM (BOSTON SCIENTIFIC)| SOLITAIRE (EV3)| TUBRIDGE FD (MICROPORT MEDICAL COMPANY)