BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 10497297 · Received September 4, 2020

    Report

    Report Number
    2017233-2020-01231
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    September 12, 2019
    Report Date
    February 17, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED B1/B2.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION B EVENT DESCRIPTION.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: ¿OUTCOMES OF FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR IN PATIENTS WITH A SOLITARY FUNCTIONAL KIDNEY¿; KEOUNA PATHER, M.D.; EMANUEL TENORIO, M.D.; JUSSI KÄRKKÄINEN, M.D.; BERNARDO MENDES, M.D.;RANDALL DEMARTINO, M.D.; THANILA MACEDO, M.D.; PETER GLOVICZKI, M.D.; GUSTAVO S. ODERICH, M.D.; FROM THE MIDWESTERN VASCULAR SURGICAL SOCIETY; PRESENTED SEPTEMBER 12, 2019; COPYRIGHT 2019 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.JVS.2019.10.062. THE AIM OF THIS PROSPECTIVE, NONRANDOMIZED STUDY WAS TO EVALUATE OUTCOMES OF FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-BEVAR) OF PARARENAL ABDOMINAL AORTIC ANEURYSMS OR THORACOABDOMINAL AORTIC ANEURYSMS (TAAAS) IN PATIENTS WITH A SOLITARY FUNCTIONAL KIDNEY (SFK), COMPARING IT WITH A CONTROL GROUP OF PATIENTS WHO HAVE TWO FUNCTIONING KIDNEYS. THE STUDY INCLUDES 287 CONSECUTIVE PATIENTS (206 MALE; MEAN AGE, 74 YEARS OLD) AND WAS CONDUCTED BETWEEN NOVEMBER 2013 AND OCTOBER 2018. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE IMPLANTED AS THE MAIN RENAL DIRECTIONAL BRANCH BRIDGING STENTS IN SIX SKF PATIENTS AND 51 FOR THE CONTROL GROUP; GORE® VIABAHN® ENDOPROSTHESES (VSX DEVICES) WERE IMPLANTED IN FIVE SKF PATIENTS AND 51 OF THE CONTROL GROUP. ADDITIONAL DEVICES USED WERE ICAST, WITH ONE FOR SKF PATIENT; SIX FOR CONTROL GROUP AND FOR ADJUNCTIVE BARE METAL STENTS, FOUR WERE FOR SKF PATIENTS; 42 FOR CONTROL GROUP. FOR ACCESSORY RENAL DIRECTIONAL BRANCHES BRIDGING STENTS, THERE WERE TWO IMPLANTS FOR THE CONTROL GROUP. FOR MAIN RENAL FENESTRATIONS BRIDGING STENTS, ICAST DEVICES WERE USED. THE ARTICLE IDENTIFIED A CONTROL GROUP IN WHICH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES STENT OCCLUSION AND REINTERVENTION WERE IDENTIFIED.

    Description of Event or Problem · 0

    COMPLAINT (B)(4) TABLE VI REFERENCES 12 POTENTIAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES RENAL ARTERY STENT OCCLUSIONS WITH REINTERVENTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: 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 · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: ¿OUTCOMES OF FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR IN PATIENTS WITH A SOLITARY FUNCTIONAL KIDNEY¿; KEOUNA PATHER, M.D.; EMANUEL TENORIO, M.D.; JUSSI KÄRKKÄINEN, M.D.; BERNARDO MENDES, M.D.;RANDALL DEMARTINO, M.D.; THANILA MACEDO, M.D.; PETER GLOVICZKI, M.D.; GUSTAVO S. ODERICH, M.D.; FROM THE MIDWESTERN VASCULAR SURGICAL SOCIETY; PRESENTED SEPTEMBER 12, 2019; COPYRIGHT 2019 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.JVS.2019.10.062. THE AIM OF THIS PROSPECTIVE, NONRANDOMIZED STUDY WAS TO EVALUATE OUTCOMES OF FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-BEVAR) OF PARARENAL ABDOMINAL AORTIC ANEURYSMS OR THORACOABDOMINAL AORTIC ANEURYSMS (TAAAS) IN PATIENTS WITH A SOLITARY FUNCTIONAL KIDNEY (SFK), COMPARING IT WITH A CONTROL GROUP OF PATIENTS WHO HAVE TWO FUNCTIONING KIDNEYS. THE STUDY INCLUDES 287 CONSECUTIVE PATIENTS (206 MALE; MEAN AGE, 74 YEARS OLD) AND WAS CONDUCTED BETWEEN NOVEMBER 2013 AND OCTOBER 2018. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE IMPLANTED AS THE MAIN RENAL DIRECTIONAL BRANCH BRIDGING STENTS IN SIX SKF PATIENTS AND 51 FOR THE CONTROL GROUP; GORE® VIABAHN® ENDOPROSTHESES (VSX DEVICES) WERE IMPLANTED IN FIVE SKF PATIENTS AND 51 OF THE CONTROL GROUP. ADDITIONAL DEVICES USED WERE ICAST, WITH ONE FOR SKF PATIENT; SIX FOR CONTROL GROUP AND FOR ADJUNCTIVE BARE METAL STENTS, FOUR WERE FOR SKF PATIENTS; 42 FOR CONTROL GROUP. FOR ACCESSORY RENAL DIRECTIONAL BRANCHES BRIDGING STENTS, THERE WERE TWO IMPLANTS FOR THE CONTROL GROUP. FOR MAIN RENAL FENESTRATIONS BRIDGING STENTS, ICAST DEVICES WERE USED. THE ARTICLE IDENTIFIED IN A TABLE ARE STENT OCCLUSIONS AND RE-INTERVENTIONS INVOLVING A VBX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960035 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R