BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20754895 · Received November 21, 2024

    Report

    Report Number
    2017233-2024-05529
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 10, 2024
    Report Date
    February 10, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: C19 - THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE REPORTED PRIMARY FAILURE MODE, RELATED TO PARTIAL DEVICE EXPANSION DUE TO A STUCK DEPLOYMENT LINE, IS NOT CONSISTENT WITH THE ENGINEERING EVALUATION FINDINGS OF THE ABILITY TO CONTINUE DEPLOYMENT OF THE DEVICE WITH TRACTION AT THE ENDOPROSTHESIS. HOWEVER, THE ENGINEERING EVALUATION CONFIRMED THAT THE DEVICE WAS PARTIALLY DEPLOYED WITH PARTIAL DEVICE EXPANSION. THE ROOT CAUSE OF THE REPORTED PRIMARY FAILURE MODE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THE RETURNED DEVICE EXHIBITED SEVERAL FORMS OF DAMAGE (E.G. EXPOSED DISTAL APICES, DELAMINATED AND BENT STRUTS, SHIFTED ENDOPROSTHESIS, EXPOSED DISTAL SHAFT). THE CAUSE FOR THESE DAMAGES COULD NOT BE DETERMINED, BUT THEY ARE CONSISTENT WITH DAMAGE RESULTING FROM AN UNKNOWN DEVICE INTERACTION DURING WITHDRAWAL OR MANIPULATION OF THE DEVICE EITHER DURING OR AFTER THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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 WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TO BE IMPLANTED WITH 7 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA) PERIPHERAL ARTERY OCCLUSIVE DISEASE (PAOD). THE VIABAHN DEVICE WAS ADVANCED THROUGH BOSTON V18 WIRE VIA TERUMO SHEATH TO TARGET LESION. WHEN THE PHYSICIAN PULLED OUT 30 CM DEPLOYMENT LINE, IT WAS STUCK AND PARTIALLY EXPANDED. IT WAS REMOVED WITH SHEATH OUT OF PATIENT. ANOTHER VIABAHN DEVICE WITH SAME SIZE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798618 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown