BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21214590 · Received January 23, 2025

    Report

    Report Number
    2017233-2025-05748
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 6, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS DISCARDED AND COULDN'T BE RETURNED FOR EVALUATION. H6: C19: THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE PRIMARY REPORTED COMPLAINT COULD NOT BE INDEPENDENTLY CONFIRMED BECAUSE THERE WERE NO ITEMS RETURNED FOR EVALUATION. THEREFORE, AN INDEPENDENT ASSESSMENT OF DEPLOYMENT PERFORMANCE COULD NOT BE CONDUCTED. PROCEDURAL DEPLOYMENT OF THE DEVICE CAN BE IMPACTED BY DIFFERENT FACTORS INCLUDING BUT NOT LIMITED TO ZIPPER INTEGRITY, DELIVERY SYSTEM SUPPORT OR STIFFNESS, OR PRESENCE OF DRIED FLUID ON THE DEVICE OR WITHIN THE CATHETER DUAL LUMEN. THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION.

    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

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF RECONSTRUCTION FOR LEFT RENAL ARTERY USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. DURING THE PROCEDURE, AFTER VIABAHN DEVICE WAS ADVANCED TO THE LEFT RENAL ARTERY, THE PHYSICIAN WITHDREW THE SHEATH. THEN THE PHYSICIAN DEPLOYED THE DEVICE, THE DEPLOYMENT LINE GOT STUCK AFTER THE DEVICE WAS DEPLOYED FOR 2/3. IT WAS FOUND THAT THE VIABAHN WAS KINKED IN THE PATIENT. THE SHAPE OF THE VIABAHN WAS ABNORMAL SO IT WAS REMOVED. THE ABNORMAL SHAPE WAS AFFECTED BY THE TORTUOUS AND NARROW VESSELS. THE RENAL ARTERY COULD BE COMPLETELY ALIGNED WITH THE ENTRY OF RENAL ARTERY. FINALLY, NO STENT WAS USED FOR THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083720 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male