BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 11562399 · Received March 24, 2021

    Report

    Report Number
    2017233-2021-01794
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    May 14, 2020
    Report Date
    March 24, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER REPORT NUMBERS THAT WERE SUBMITTED BASED ON THIS PUBLICATION ARE: 2017233-2020-00116, 2017233-2020-00118, 2017233-2020-00119, AND 2017233-2020-00120. PERFORMANCE OF VIABAHN BALLOON-EXPANDABLE STENT COMPARED WITH SELF-EXPANDABLE COVERED STENTS FOR BRANCHED ENDOVASCULAR AORTIC REPAIR. AUTHORS: FERNANDO MOTTA, MD, F. EZEQUIEL PARODI, MD, MARTYN KNOWLES, MD, MBA, JASON R. CROWNER, MD, LUIGI PASCARELLA, MD, KATHARINE L. MCGINIGLE, MD, MPH, WILLIAM A. MARSTON, MD, MELINA R. KIBBE, MD, ELAD OHANA, RT(R)(CI)(VI), AND MARK A. FARBER, MD, CHAPEL HILL, NC. SOCIETY FOR VASCULAR SURGERY.

    Additional Manufacturer Narrative · 1

    ARTICLE: PERFORMANCE OF VIABAHN BALLOON-EXPANDABLE STENT COMPARED WITH SELF-EXPANDABLE COVERED STENTS FOR BRANCHED ENDOVASCULAR AORTIC REPAIR. AUTHORS: FERNANDO MOTTA, MD, F. EZEQUIEL PARODI, MD, MARTYN KNOWLES, MD, MBA, JASON R. CROWNER, MD, LUIGI PASCARELLA, MD, KATHARINE L. MCGINIGLE, MD, MPH, WILLIAM A. MARSTON, MD, MELINA R. KIBBE, MD, ELAD OHANA, RT(R)(CI)(VI), AND MARK A. FARBER, MD, CHAPEL HILL, NC. SOCIETY FOR VASCULAR SURGERY. HTTPS://DOI.ORG/10.1016/J.JVS.2020.05.028. AVERAGE AGE AND GENDER ARE BASED ON ARTICLE INFORMATION. PATIENT AND EVENT INFORMATION WERE REQUESTED, BUT AUTHOR DECLINED TO PROVIDE ANY DETAILS. AS A RESULT, FURTHER INVESTIGATION WAS NOT POSSIBLE. 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

    REVIEW WAS ARTICLE TITLED, PERFORMANCE OF VIABAHN BALLOON-EXPANDABLE STENT COMPARED WITH SELF-EXPANDABLE COVERED STENTS FOR BRANCHED ENDOVASCULAR AORTIC REPAIR. AUTHORS: FERNANDO MOTTA, MD, F. EZEQUIEL PARODI, MD, MARTYN KNOWLES, MD, MBA, JASON R. CROWNER, MD, LUIGI PASCARELLA, MD, KATHARINE L. MCGINIGLE, MD, MPH, WILLIAM A. MARSTON, MD, MELINA R. KIBBE, MD, ELAD OHANA, RT(R)(CI)(VI), AND MARK A. FARBER, MD, CHAPEL HILL, NC. SOCIETY FOR VASCULAR SURGERY, VOL 73 NO. 2. ACCEPTED MAY 14, 2020. THE STUDY OBJECTIVE WAS TO COMPARE THE PERFORMANCE BETWEEN GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) AND SELF-EXPANDING COVERED STENTS (SES; GORE® VIABAHN® ENDOPROSTHESIS AND FLUENCY¿ PLUS ENDOVASCULAR STENT GRAFT) THAT WERE USED AS BRIDGING STENTS FOR DIRECTIONAL BRANCHES DURING FENESTRATED-BRANCHED ENDOVASCULAR ANEURYSM REPAIR OF COMPLEX AORTIC ANEURYSMS. INCLUDED WERE 62 PATIENTS AND 177 (96 VBX AND 81 SES) BRANCHES IMPLANTED BETWEEN JULY 2012 AND JUNE 2019. THERE WAS NO BRANCH-RELATED RUPTURE OR MORTALITY. PRIMARY PATENCY AT 24 MONTHS (VBX, 98.1%; SES, 98.6%), FREEDOM FROM ENDOLEAK (VBX, 95.6%; SES, 98.6%;), FREEDOM FROM SECONDARY INTERVENTION (VBX, 94.7%; SES, 98.1%), AND FREEDOM FROM BRANCH INSTABILITY (VBX, 95.6%; SES) WERE SIMILAR BETWEEN GROUPS. THE MEDIAN AGE OF THE PATIENTS TREATED WITH A BRANCH WAS 68.5 YEARS (63-75 YEARS); 66% WERE MALE. REPORTED IN THIS PUBLICATION IS A TYPE IC ENDOLEAK WITH VBX DEVICE. THE PATIENT WITH CELIAC ARTERY COMPLICATIONS HAD ENDOLEAK EXCLUSION AT COMPLETION OF SECONDARY INTERVENTION WITH STENT EXTENSIONS DISTALLY (VBX FOR THE VBX EXTENSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456685 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention