BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 17061634 · Received June 5, 2023

    Report

    Report Number
    2017233-2023-03981
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    December 1, 2022
    Report Date
    June 5, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. THE DEVICE WAS NOT RETURNED TO W. L. GORE & ASSOCIATES, INC., THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THIS INFORMATION. ACCORDING TO THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE INSTRUCTIONS FOR USE (IFU), WARNING: THIS DEVICE CONTAINS NITINOL, AN ALLOY OF NICKEL AND TITANIUM. PERSONS WITH ALLERGIC REACTIONS TO THESE METALS MAY SUFFER AN ALLERGIC REACTION TO THIS IMPLANT. PRIOR TO IMPLANTATION, PATIENTS SHOULD BE COUNSELED ON THE MATERIALS CONTAINED IN THE DEVICE, AS WELL AS POTENTIAL FOR ALLERGY TO THE MATERIALS. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. LITERATURE CITATION: RHUSHEET PATEL, WESLEY MOORE, JUAN CARLOS JIMENEZ, SEVERE SYMPTOMATIC NICKEL ALLERGY FOLLOWING STENT GRAFT IMPLANTATION REQUIRING EXCISION AND EXTERNAL ILIAC ARTERY RECONSTRUCTION, JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, VOLUME 8, ISSUE 4, 2022, PAGES 562-564, ISSN 2468-4287, HTTPS://DOI.ORG/10.1016/J.JVSCIT.2022.08.013. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S2468428722001526) 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. 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.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: RHUSHEET PATEL, WESLEY MOORE, JUAN CARLOS JIMENEZ (CORRESPONDENCE) "SEVERE SYMPTOMATIC NICKEL ALLERGY FOLLOWING STENT GRAFT IMPLANTATION REQUIRING EXCISION AND EXTERNAL ILIAC ARTERY RECONSTRUCTION" JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, VOLUME 8, ISSUE 4, DECEMBER 2022, PAGES 562-564, ISSN 2468-4287, HTTPS://DOI.ORG/10.1016/J.JVSCIT.2022.08.013. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S2468428722001526) ABSTRACT: ALTHOUGH NICKEL ALLERGY IS A COMMON CAUSE OF CONTACT DERMATITIS, SYSTEMIC REACTIONS TO NITINOL STENTS ARE RARE. A 61-YEAR-OLD WOMAN HAD PRESENTED WITH A NONHEALING TOE WOUND. ANGIOGRAPHY REVEALED AN EXTERNAL ILIAC ARTERY STENOSIS, WHICH WAS TREATED WITH A NITINOL STENT GRAFT. HOWEVER, SHE DEVELOPED SEVERE TRUNCAL PRURITUS, AND WITHIN 3 MONTHS, HER EXTERNAL ILIAC STENT GRAFT HAD THROMBOSED. ALLERGY TESTING REVEALED NICKEL SENSITIVITY. AFTER MEDICAL THERAPY HAD FAILED, STENT GRAFT REMOVAL WAS PERFORMED, RESULTING IN COMPLETE RESOLUTION OF HER SYMPTOMS. THE PRESENT CASE DEMONSTRATES A RARE ALLERGIC REACTION TO THE NITINOL IN COMMERCIALLY AVAILABLE STENT GRAFTS. PRURITUS AND RASH ARE RARE REACTIONS TO STENTING; HOWEVER, A NITINOL ALLERGY SHOULD BE CONSIDERED FOR PATIENTS WITH NO OTHER IDENTIFIABLE PRIMARY SOURCE. CONCLUSIONS THE PRESENT CASE HAS DEMONSTRATED A RARE ALLERGIC REACTION TO THE NITINOL COMPONENTS OF COMMERCIALLY AVAILABLE STENT GRAFTS. COMPLETE STENT EXCISION AND REVASCULARIZATION CAN BE REQUIRED FOR SYMPTOM RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30607 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other