BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10024390 · Received May 5, 2020

    Report

    Report Number
    2017233-2020-00318
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    January 28, 2015
    Report Date
    September 4, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; - MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. - LOT #UNKNOWN - CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. [(B)(4)].

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: ¿SAFETY AND EFFICACY OF USING THE VIABAHN ENDOPROSTHESIS FOR PERCUTANEOUS TREATMENT OF VASCULAR ACCESS COMPLICATIONS AFTER TRANSFEMORAL AORTIC VALVE IMPLANTATION¿ (OLE DE BACKER ET AL., THE AMERICAN JOURNAL OF CARDIOLOGY, ACCEPTED JANUARY 28, 2015). OVER A 40-MONTH PERIOD, A TOTAL OF 380 PATIENTS UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN A SINGLE-CENTER USING THE SELF-EXPANDING COREVALVE (MEDTRONIC, MINNEAPOLIS, MN). ACCESS-RELATED COMPLICATIONS (VAC) LEADING TO ACUTE INTERVENTION OCCURRED IN 72 PATIENTS (20.3%) OF THE STUDY POPULATION. MINOR VASCULAR INJURY AT THE PUNCTURE SITE WAS TREATED WITH EITHER EXTERNAL COMPRESSION OR BALLOON ANGIOPLASTY FOR 3 TO 5 MINUTES. IF THIS STRATEGY FAILED OR WHEN MAJOR EXTRAVASATION WAS APPARENT ON ANGIOGRAPHIC CONTROL, A 50-MM-LONG GORE® VIABAHN® ENDOPROSTHESES (VB) WAS INSERTED COVERING THE VESSEL LESION, AIMING TO PLACE THE DISTAL PART OF THE STENT PROXIMAL TO THE BIFURCATION OF THE COMMON FEMORAL ARTERY (CFA) INTO SUPERFICIAL FEMORAL ARTERY (SFA) AND DEEP FEMORAL ARTERY (DFA). VB WERE USED FOR DIFFERENT TYPES OF VAC: STENOSIS (N=3), DISSECTION (N=4), INCOMPLETE VASCULAR CLOSURE DUE TO CLOSURE DEVICE FAILURE (N=36), AND RUPTURE/PERFORATION (N=5). THE USE OF VB WAS THE PRIMARY CHOICE IN 38 PATIENTS, WHEREAS IN 10 OTHER PATIENTS, STENTING WAS PRECEDED BY BALLOON ANGIOPLASTY WITH UNSATISFACTORY RESULT. FOLLOW-UP DATA ON THE VB SUBGROUP WERE OBTAINED IN 44 OF 48 PATIENTS (MEDIAN FOLLOW-UP TIME: 372 DAYS). IT WAS STATED THAT THE VB WAS COVERING THE DFA IN 3 PATIENTS, WHICH RESULTED IN NEW-ONSET CLAUDICATION IN ONE OF THESE PATIENTS, WHEREAS 2 OTHERS REMAINED ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489822 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention