BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 24560038 · Received March 10, 2026

    Report

    Report Number
    2017233-2026-07243
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 25, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132623747
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER (IN CONFIDENCE) REFLECT THE GORE INTERNAL CASE NUMBER. THE FOLLOWING PATIENT INFORMATION WAS ASKED TO THE PHYSICIAN BUT WAS NOT AVAILABLE: INITIALS, GENDER, AGE, WEIGHT, DATE OF BIRTH, COMORBIDITIES, MEDICATIONS. 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.

    Additional Manufacturer Narrative · 0

    UPDATED H6 ADVERSE EVENT PROBLEM CODES INVESTIGATION CODES. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. PRODUCT RETURN EVALUATION: THE REPORTED FAILURE TO INITIATE DEPLOYMENT DUE TO A STUCK DEPLOYMENT LINE, WAS CONSISTENT WITH THE ENGINEERING EVALUATION FINDINGS OF AN INABILITY TO DEPLOY THE DEVICE AT THE KNOB OR WITH TRACTION AT THE ENDOPROSTHESIS. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR THE PRIMARY DEVICE FAILURE MODE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE INVOLVING THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR AN UNKNOWN ETIOLOGY. DURING THE PROCEDURE, THE DELIVERY CATHETER ADVANCED NORMALLY VIA AN UP-AND-OVER CONTRALATERAL APPROACH USING A 6F INTRODUCER SHEATH FROM AN UNSPECIFIED MANUFACTURER OVER AN 0.018" GLIDEWIRE ADVANTAGE AND TO THE INTENDED TREATMENT LOCATION. WHEN ATTEMPTING TO DEPLOY THE DEVICE, THE OPERATOR WAS UNABLE TO INITIATE DEPLOYMENT; THE DEPLOYMENT LINE APPEARED STUCK. THE SYSTEM WAS SUBSEQUENTLY WITHDRAWN WITHOUT RESISTANCE, AND THE ENDOPROSTHESIS REMAINED FULLY CONSTRAINED UPON REMOVAL. REPORTEDLY, THERE WAS AN UNSUCCESSFUL ATTEMPT TO DEPLOY THE ENDOPROSTHESIS ON THE BACK TABLE. THE EVENT HAD NO REPORTED IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621046 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132623747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male