BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 13664101 · Received March 3, 2022

    Report

    Report Number
    2017233-2022-02783
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    January 4, 2022
    Report Date
    May 2, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132637133
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNCLEAR AS TO THE IDENTIFICATION OF WHICH DEVICE/DEVICES FAILED WITHIN THE PROCEDURE, SO ALL 3 WILL BE INCLUDED IN THE NARRATIVE AND MANUFACTURING RECORDS WERE PULLED FOR ALL 3 DEVICES USED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT # 20315585 INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT # 21271667 INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT # 24277912 INDICATED THE LOT MET PRE-RELEASE MANUFACTURING SPECIFICATIONS. DUE TO NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    INFORMATION OBTAINED FROM MEDRIO STUDY DATABASE: FILE NAME: L-CHANGE-REINT_20220201. RECVD: 2/4/2022. SIDE BRANCH (VBX) BXA055902A/ 20315585 USED IN RIGHT RENAL ARTERY (MOST PROXIMAL WITHIN THE PORTAL) SIDE BRANCH (VBX) BXA071902A/21271667 USED IN RIGHT RENAL ARTERY (FIRST DISTAL EXTENSION) SIDE BRANCH (VBX) BXA 053902A/24277912 USED IN RIGHT RENAL ARTERY (MOST PROXIMAL WITHIN THE PORTAL) PROCEDURE DATE: (B)(6) 2019 DR (B)(6). THE UNIVERSITY OF (B)(6). WHITE MALE, DOB (B)(6) 1935, WEIGHT (B)(6). COMORBIDITIES: CORONARY ARTERY BYPASS GRAFT, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, HYPERTENSION, ATRIAL FIBRILLATION, AND COLORECTAL CANCER. MEDICATIONS: ASPIRIN, WARFARIN, STUDY PT: (B)(6). ADVERSE EVENT - 03 DATE OF ONSET - POSSIBLE RIGHT RENAL ARTERY STENT CRUSHED/SLIGHTLY NARROWED RITYPE: PROCEDURE DONE ON (B)(6) 2022, HAD STENT PLACED (VBX 5 X 39 AND AN ICAST 6 X 38)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683355 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. BXA055902A 00733132637133

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Hospitalization| R| O