BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 22589500 · Received July 24, 2025

    Report

    Report Number
    2017233-2025-06446
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 21, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132645824
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. THE PRIMARY REPORTED COMPLAINT, RELATED TO DIFFICULTY REMOVING THE CATHETER AFTER DEPLOYMENT, COULD NOT BE INDEPENDENTLY CONFIRMED BECAUSE NO PRODUCT NOR IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. THEREFORE, AN INDEPENDENT ASSESSMENT OF DEPLOYMENT PERFORMANCE COULD NOT BE CONDUCTED. THE CAUSE FOR THE PRIMARY REPORTED COMPLAINT COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THE SECONDARY REPORTED COMPLAINT, RELATED TO DISTAL TIP SEPARATION DURING WITHDRAWAL, COULD NOT BE INDEPENDENTLY CONFIRMED BECAUSE NO PRODUCT NOR IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. THEREFORE, AN INDEPENDENT ASSESSMENT OF DEPLOYMENT PERFORMANCE COULD NOT BE CONDUCTED. AS REPORTED, RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPTED WITHDRAWAL OF THE DELIVERY SYSTEM POST-DEPLOYMENT; THE PHYSICIAN APPLIED ADDITIONAL FORCE, AND UPON REMOVAL, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED AND REMAINED WITHIN THE PATIENT. PER THE DEVICE IFU, IF THE TIP OF THE DELIVERY CATHETER CATCHES ON THE LEADING EDGE OF THE INTRODUCER SHEATH DURING CATHETER REMOVAL, A SLIGHT ¿BACK AND FORTH¿ MOTION OF THE CATHETER OR REPOSITIONING OF THE SHEATH MAY AID IN RELEASE. THE IFU ALSO NOTES THAT EXCESSIVE OR ABRUPT FORCE DURING CATHETER REMOVAL MAY DAMAGE THE DELIVERY CATHETER. THEREFORE, THE CAUSE FOR THE SECONDARY REPORTED COMPLAINT CAN BE ATTRIBUTED TO THE REASONABLY FORESEEABLE MISUSE OF THE DELIVERY CATHETER BEING WITHDRAWN FORCEFULLY. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION TO ADDRESS GENERALIZED ARTERIAL DISEASE INVOLVING THE LEFT EXTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS SUCCESSFULLY DEPLOYED AT THE INTENDED TREATMENT SITE. THE DEVICE WAS ADVANCED AND IMPLANTED WITHOUT RESISTANCE USING AN 8FR COOK MEDICAL INTRODUCER SHEATH AND A TERUMO 0.035" GLIDEWIRE ADVANTAGE® GUIDEWIRE. DURING THE ATTEMPTED WITHDRAWAL OF THE VIABAHN DELIVERY SYSTEM THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED ADDITIONAL FORCE, AND UPON REMOVAL, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE DETACHED COMPONENT WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PATIENT¿S VASCULAR ANATOMY DEMONSTRATED TYPICAL CALCIFICATION AND TORTUOSITY. THERE WERE NO REPORTED ADVERSE EFFECTS OR CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859488 GORE® VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132645824

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male