BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 9843697 · Received March 17, 2020

    Report

    Report Number
    2017233-2020-00155
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    March 17, 2018
    Report Date
    May 5, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT TASK - MANUFACTURE PLANT.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLISHED ARTICLE WAS REVIEWED: 'OUTCOMES OF AN ILIAC BRANCH ENDOPROSTHESIS USING AN ¿UP-AND-OVER¿ TECHNIQUE FOR ENDOVASCULAR REPAIR OF FAILED BIFURCATED GRAFTS'; EMANUEL R. TENORIO, MD, PHD, GUSTAVO S. ODERICH, MD, GIULIANO A. SANDRI, MD, JUSSI M. KÄRKKÄINEN, MD, PHD, MANJU KALRA, MBBS, RANDALL R. DEMARTINO, MD, JILL K. JOHNSTONE, MD, AND FAHAD SHUJA, MBBS, ROCHESTER, MINN; PRESENTED AT THE FORTY-SIXTH ANNUAL SYMPOSIUM OF THE SOCIETY FOR CLINICAL VASCULAR SURGERY, LAS VEGAS, NEV, MARCH 17-21, 2018; 0741-5214; COPYRIGHT 2018 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.JVS.2018.10.098. THE AIM OF THIS STUDY WAS TO EVALUATE OUTCOMES OF THE IBE USING AN ¿UP-AND-OVER¿ TRANSFEMORAL TECHNIQUE IN PATIENTS WITH PRIOR AORTIC REPAIR COMPARED WITH THE STANDARD TECHNIQUE IN PATIENTS WITH DE NOVO ILIAC ANEURYSMS. THERE WERE 53 PATIENTS (51 MALE; AVG. 74 YEARS OLD) TREATED BY 62 IBES. THE ARTICLE REPORTED THAT SECONDARY INTERVENTION WAS REQUIRED BECAUSE OF TYPE IB ENDOLEAK (PROXIMAL) IN THE EXTERNAL ILIAC LIMB. THE ARTICLE IS UNCLEAR ABOUT WHICH DEVICE WAS USED. NOTE: THE ARTICLE REPORTS THAT THE BRIDGING STENT OF CHOICE WAS PREFERENTIALLY AN 8L VIABAHN BALLOON-EXPANDABLE ENDOPROSTHESIS (VBX; W.L. GORE & ASSOCIATES), WHICH WAS ADVANCED OVER THE AMPLATZ GUIDEWIRE. WHEN THAT WAS NOT AVAILABLE, THE ICAST (ATRIUM MEDICAL, MERRIMACK, NH) STENT GRAFT WAS SELECTED. GORE® VIABAHN® ENDOPROSTHESIS WAS ALSO USED AS A BRIDGING STENT IN THE IIA.

    Additional Manufacturer Narrative · 1

    THE ARTICLE INDICATED BOTH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS & GORE® VIABAHN® ENDOPROSTHESIS WERE INVOLVED. HOWEVER, THE ARTICLE DID NOT PROVIDE SPECIFICS. REFERENCE MDR #2017233-2020-00154 FOR GORE® VIABAHN® ENDOPROSTHESIS REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLISHED ARTICLE WAS REVIEWED: 'OUTCOMES OF AN ILIAC BRANCH ENDOPROSTHESIS USING AN ¿UP-AND-OVER¿ TECHNIQUE FOR ENDOVASCULAR REPAIR OF FAILED BIFURCATED GRAFTS'; EMANUEL R. TENORIO, MD, PHD, GUSTAVO S. ODERICH, MD, GIULIANO A. SANDRI, MD, JUSSI M. KÄRKKÄINEN, MD, PHD, MANJU KALRA, MBBS, RANDALL R. DEMARTINO, MD, JILL K. JOHNSTONE, MD, AND FAHAD SHUJA, MBBS, ROCHESTER, MINN; PRESENTED AT THE FORTY-SIXTH ANNUAL SYMPOSIUM OF THE SOCIETY FOR CLINICAL VASCULAR SURGERY, LAS VEGAS, NEV, MARCH 17-21, 2018; 0741-5214; COPYRIGHT 2018 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.JVS.2018.10.098. THE AIM OF THIS STUDY WAS TO EVALUATE OUTCOMES OF THE IBE USING AN ¿UP-AND-OVER¿ TRANSFEMORAL TECHNIQUE IN PATIENTS WITH PRIOR AORTIC REPAIR COMPARED WITH THE STANDARD TECHNIQUE IN PATIENTS WITH DE NOVO ILIAC ANEURYSMS. THERE WERE 53 PATIENTS (51 MALE; AVG. 74 YEARS OLD) TREATED BY 62 IBES. THE ARTICLE REPORTED THAT SECONDARY INTERVENTION WAS REQUIRED BECAUSE OF TYPE IB ENDOLEAK (PROXIMAL) IN THE EXTERNAL ILIAC LIMB. THE ARTICLE IS UNCLEAR ABOUT WHICH DEVICE WAS USED. NOTE: THE ARTICLE REPORTS THAT THE BRIDGING STENT OF CHOICE WAS PREFERENTIALLY AN 8L VIABAHN BALLOON-EXPANDABLE ENDOPROSTHESIS (VBX; W.L. GORE & ASSOCIATES), WHICH WAS ADVANCED OVER THE AMPLATZ GUIDEWIRE. WHEN THAT WAS NOT AVAILABLE, THE ICAST (ATRIUM MEDICAL, MERRIMACK, NH) STENT GRAFT WAS SELECTED. GORE® VIABAHN® ENDOPROSTHESIS WAS ALSO USED AS A BRIDGING STENT IN THE IIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308287 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention