BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 19397914 · Received May 24, 2024

    Report

    Report Number
    2017233-2024-04990
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    February 1, 2024
    Report Date
    July 8, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED, AND THE INFORMATION PROVIDED TO GORE CANNOT BE CONNECTED TO A SPECIFIC DEVICE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. H6: REMOVED CODE D16 AND ADDED CODE D1002 UNDER INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: FIGUEROA AV, TANENBAUM MT, COSTA FILHO JE, GONZALEZ MS, CORONEL NI, BAIG MS, TIMARAN CH, LONG-TERM OUTCOMES OF STAGED ILIOFEMORAL ENDOCONDUITS PRIOR TO COMPLEX ENDOVASCULAR AORTIC ANEURYSM REPAIR, JOURNAL OF VASCULAR SURGERY (2024), DOI: HTTPS://DOI.ORG/10.1016/ J.JVS.2024.02.001. THIS STUDY DESCRIBES THE LONG-TERM RESULTS OF ILIOFEMORAL ECS [ENDOCONDUITS] PRIOR TO COMPLEX EVAR [ENDOVASCULAR AORTIC ANEURYSM REPAIR]. THIS IS A SINGLE CENTER RETROSPECTIVE STUDY BETWEEN 2012 AND 2023. 59 PATIENTS UNDERWENT ECS BEFORE COMPLEX EVAR USING SELF-EXPANDING STENTS (GORE® VIABAHN® ENDOPROSTHESIS). TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL ACCESS, CLOSURE, AND DELIVERY OF THE ENDOGRAFT DURING COMPLEX EVAR. ENDPOINTS WERE VASCULAR INJURY OR EC DISRUPTION, SECONDARY INTERVENTIONS, AND EC PATENCY. A SELF-EXPANDING COVERED STENT (GORE® VIABAHN® ENDOPROSTHESIS; W.L. GORE & ASSOCIATES) IS DEPLOYED INTO THE MID-SEGMENT OF THE CFA. PREDILATATION WITH A 4- TO 5-MM ANGIOPLASTY BALLOON IS PERFORMED SELECTIVELY FOR PATIENTS WITH SEVERE ILIAC OR FEMORAL ARTERY STENOSIS. INTERNAL ILIAC ARTERY (IIA) PATENCY IS MAINTAINED WHEN FEASIBLE. AFTER STENTING, HIGH-PRESSURE BALLOON ANGIOPLASTY OF THE STENTED VESSEL IS PERFORMED USING THE ¿PAVE AND CRACK¿ TECHNIQUE. PATENCY IS CONFIRMED WITH AN ANGIOGRAM. THE FEMORAL ACCESS IS THEN CLOSED WITH THE PREVIOUSLY PLACED PERCLOSE DEVICE OR ANOTHER CLOSURE DEVICE. UNILATERAL EC WAS PERFORMED IN 45 PATIENTS (76%). ECS WERE EXTENDED INTO THE CFA IN 21 PATIENTS (35%). SIX PATIENTS (10%) HAD AN INTRAOPERATIVE VASCULAR INJURY DURING THE EC PROCEDURE REQUIRING OPEN CONVERSION AND REPAIR OF THE GROIN ACCESS. ONE EC OCCLUDED BEFORE COMPLEX EVAR, REQUIRING THROMBECTOMY AND RE-STENTING DURING THE SECOND-STAGE PROCEDURE. SIX PATIENTS (10%) HAD EC DISRUPTION DURING COMPLEX EVAR, INCLUDING FIVE EC COLLAPSES REQUIRING RE-STENTING AND ONE EC FRACTURE REQUIRING OPEN CUT-DOWN AND RECONSTRUCTION WITH PATCH ANGIOPLASTY. TECHNICAL SUCCESS FOR ACCESSING EC WAS 89%. THERE WAS NO DIFFERENCE IN MAJOR ADVERSE EVENTS AT 30 DAYS BETWEEN THE ILIAC ECS AND ILIOFEMORAL ECS. PRIMARY PATENCY BY KAPLAN-MEIER ESTIMATES AT 1, 3, AND 5 YEARS WERE 97.5%, 89%, AND 82%, RESPECTIVELY. IN CONCLUSION ECS IMPROVE VASCULAR ACCESS, AND THEIR USE PRIOR TO COMPLEX EVAR IS ASSOCIATED WITH LOW RATES OF VASCULAR INJURY, HIGH TECHNICAL SUCCESS, AND OPTIMAL LONG-TERM PATENCY. COMPLEX EVAR PROCEDURES CAN BE PERFORMED PERCUTANEOUSLY BY ACCESSING THE EC DIRECTLY UNDER ULTRASOUND GUIDANCE AND USING SEQUENTIAL DILATION TO AVOID EC DISRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663604 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization