BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 14882109 · Received June 30, 2022

    Report

    Report Number
    2017233-2022-03086
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    January 11, 2020
    Report Date
    August 2, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 0

    REMOVE C1. H6: 213-DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. CITATION: JUN BAI, YANDONG LIU, JIE JIN, JIANJIN WU. MID-TERM RESULTS OF IN SITU FENESTRATION STENTED WITH BALLOON-EXPANDABLE BARE METAL STENTS DURING THORACIC ENDOVASCULAR AORTIC REPAIR. CATHETER CARDIOVASC INTERV. 2020; 95:1163¿1168. DOI: 10.1002/CCD.28743.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿MID-TERM RESULTS OF IN SITU FENESTRATION STENTED WITH BALLOON-EXPANDABLE BARE METAL STENTS DURING THORACIC ENDOVASCULAR AORTIC REPAIR¿ PUBLISHED BY CATHETER CARDIOVASC INTERV. 2020; 95:1163¿1168. THE STUDY WAS TO ASSESS THE SAFETY, FEASIBILITY AND EFFECTIVENESS OF BALLOON-EXPANDABLE BARE METAL STENTS (BMS) AS BRIDGE STENTS DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THE RESULTS STATE IN THE SERIES, ONE CASE WITH AN 8*50 MM VIABAHN®-COVERED STENT HAD A 50% RESIDUAL STENOSIS IN THE CONNECTING PART OF AORTIC GRAFT AND BRIDGING STENT AFTER PRE-DILATION. THE STENOSIS WAS NOT RESOLVED AFTER SEVERAL DILATIONS, BUT IT WAS RESOLVED AFTER ANOTHER 8*37-MM BALLOON-EXPANDABLE BARE STENT WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009159 GORE® VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention