BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21511455 · Received March 3, 2025

    Report

    Report Number
    2017233-2025-05882
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    October 30, 2023
    Report Date
    March 24, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    04993024010154
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS B3, B5 WERE UPDATED. DEVICE INFORMATION (SERIAL#, CATALOG#, MANUFACTURE DATE, EXPIRATION DATE, IMPLANT DATE) WAS ADDED. H6: CODE B14 WAS ADDED: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. LITERATURE TITLE: INFECTION OF VIABAHN STENT GRAFT FOLLOWING FEMORAL CELLULITIS 7 MONTHS POST-SURGERY: A CASE REPORT SOURCE: METROPOLITAN VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 43, ISSUE 1, PAGES 172-173. 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.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: YU AYAKA ET AL. ¿INFECTION OF VIABAHN STENT GRAFT FOLLOWING FEMORAL CELLULITIS 7 MONTHS POST-SURGERY: A CASE REPORT¿ METROPOLITAN VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 43, ISSUE 1, PAGES 172-173. A 62-YEAR-OLD FEMALE PATIENT PRESENTED WITH SEVERE INTERMITTENT CLAUDICATION DUE TO RIGHT LOWER LIMB ARTERIOSCLEROSIS OBLITERANS. ON APRIL 19, 2023, SHE UNDERWENT A THROMBOENDARTERECTOMY OF THE RIGHT COMMON FEMORAL ARTERY (CFA) AND PLACEMENT OF A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR CFA STENOSIS WITH SEVERE CALCIFICATION AND SFA OCCLUSION. POSTOPERATIVE RECOVERY WAS INITIALLY GOOD, BUT ON JUNE 28, 2023, SHE DEVELOPED CELLULITIS IN THE RIGHT INNER THIGH, WHICH WAS TREATED WITH ANTIBIOTICS. ON SEPTEMBER 8, 2023, THE CELLULITIS RECURRED, AND A CT SCAN REVEALED AN ABSCESS ADJACENT TO THE SFA, WHICH WAS OCCLUDED. MSSA WAS DETECTED, AND THE ABSCESS WAS DRAINED. HOWEVER, ON OCTOBER 30, 2023, THE INFECTION WORSENED, AND A CT SCAN SHOWED AN ABSCESS AROUND THE VIABAHN. ALSO, OCCLUSION OF THE VIABAHN WAS NOTED. SURGICAL FINDINGS INCLUDED A RUPTURE OF THE SUPERFICIAL FEMORAL ARTERY WALL AND PUS ACCUMULATION. THE VIABAHN AND THE AFFECTED SEGMENT OF THE SFA WERE REMOVED WITHOUT REVASCULARIZATION. THE PATIENT DID NOT EXPERIENCE A RECURRENCE OF INTERMITTENT CLAUDICATION AND WAS DISCHARGED HOME ON NOVEMBER 12, 2023, CONTINUING ANTIBIOTIC THERAPY WITH NO FURTHER INFECTION RECURRENCE TO DATE. REPORTEDLY, THE OCCLUSION OF THE VIABAHN OCCURRED DUE TO INFECTION.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: YU AYAKA ET AL. ¿INFECTION OF VIABAHN STENT GRAFT FOLLOWING FEMORAL CELLULITIS 7 MONTHS POST-SURGERY: A CASE REPORT¿ METROPOLITAN VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 43, ISSUE 1, PAGES 172-173. A 62-YEAR-OLD FEMALE PATIENT PRESENTED WITH SEVERE INTERMITTENT CLAUDICATION DUE TO RIGHT LOWER LIMB ARTERIOSCLEROSIS OBLITERANS. SHE UNDERWENT A THROMBOENDARTERECTOMY OF THE RIGHT COMMON FEMORAL ARTERY (CFA) AND PLACEMENT OF A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR CFA STENOSIS WITH SEVERE CALCIFICATION AND SFA OCCLUSION. POSTOPERATIVE RECOVERY WAS INITIALLY GOOD, BUT THREE MONTHS LATER, SHE DEVELOPED CELLULITIS IN THE RIGHT INNER THIGH, WHICH WAS TREATED WITH ANTIBIOTICS. AT FIVE MONTHS POST-SURGERY, THE CELLULITIS RECURRED, AND A CT SCAN REVEALED AN ABSCESS ADJACENT TO THE SFA, WHICH WAS OCCLUDED. MSSA WAS DETECTED, AND THE ABSCESS WAS DRAINED. HOWEVER, AT SEVEN MONTHS POST-SURGERY, THE INFECTION WORSENED, AND A CT SCAN SHOWED AN ABSCESS AROUND THE VIABAHN. ALSO, OCCLUSION OF THE VIABAHN WAS NOTED. SURGICAL FINDINGS INCLUDED A RUPTURE OF THE SUPERFICIAL FEMORAL ARTERY WALL AND PUS ACCUMULATION. THE VIABAHN AND THE AFFECTED SEGMENT OF THE SFA WERE REMOVED WITHOUT REVASCULARIZATION. THE PATIENT DID NOT EXPERIENCE A RECURRENCE OF INTERMITTENT CLAUDICATION AND WAS DISCHARGED HOME ON THE 13TH POSTOPERATIVE DAY, CONTINUING ANTIBIOTIC THERAPY WITH NO FURTHER INFECTION RECURRENCE TO DATE. REPORTEDLY, THE OCCLUSION OF THE VIABAHN OCCURRED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189184 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 04993024010154

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention