BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20198378 · Received September 12, 2024

    Report

    Report Number
    2017233-2024-05302
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 12, 2024
    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

    ADD D9. H6: C19 A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. THE REPORTED PRIMARY FAILURE MODE, RELATED TO DIFFICULTY ADVANCING THE CATHETER TO THE TARGET LESION, COULD NOT BE INDEPENDENTLY CONFIRMED DURING ENGINEERING EVALUATION DUE TO DIFFERENCES BETWEEN CONDITIONS SEEN IN VIVO AND THOSE SEEN IN THE LABORATORY. AS REPORTED, THE DEVICE COULDN¿T GO FORWARD TO THE TARGET LESION DUE TO TORTUOUS ANATOMY. THEREFORE, THE ROOT CAUSE OF THE REPORTED PRIMARY FAILURE MODE OF CATHETER ADVANCEMENT DIFFICULTY CAN BE ATTRIBUTED TO THE PATIENT CONDITION. THE REPORTED SECONDARY FAILURE MODE, RELATED TO DISTAL SHAFT SEPARATION AT THE TRANSITION, WAS UNABLE TO BE CONFIRMED DURING ENGINEERING EVALUATION. HOWEVER, ENGINEERING EVALUATION DID OBSERVE A BROKEN DISTAL SHAFT JUST OUTSIDE THE TRANSITION BOND; THIS WAS ALSO VISIBLE IN THE PHOTOGRAPH OF THE DEVICE PROVIDED FROM THE FIELD. AS REPORTED, A CATHETER KINK WITH DISTAL SHAFT DETACHMENT OCCURRED FOLLOWING THE ADVANCEMENT DIFFICULTY AND REPEATED MANIPULATION BY THE OPERATOR, WHICH WAS NOTED TO HAVE BEEN DUE TO THE PATIENT CONDITION. WHILE THE CAUSE OF THE REPORTED DISTAL SHAFT DETACHMENT MAY BE DUE TO FORCES EXHIBITED ON THE DEVICE DURING DIFFICULTY ADVANCING AT THE TIME OF THE PROCEDURE, A RELATIONSHIP BETWEEN THE REPORTED ADVANCEMENT DIFFICULTY DUE TO THE PATIENT CONDITION AND THE DISTAL SHAFT BREAKAGE COULD BE NEITHER DEFINITIVELY CONFIRMED NOR DISMISSED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE OF DISTAL SHAFT DETACHMENT 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.

    Additional Manufacturer Narrative · 0

    UPDATE INVESTIGATION FINDING C24.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TO BE IMPLANTED WITH 8MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) DURING THE PTA SURGERY. WHEN THE PHYSICIAN ADVANCED VIABAHN DEVICE VIA 8FR TERUMO SHEATH TO RIGHT SUBCLAVIAN ARTERY, IT COULDN'T GO FORWARD TO THE TARGET LESION CAUSING BY THE TORTUOUS ANATOMY AND REPEATEDLY MANIPULATION BY OPERATOR. AS A RESULT, AFTER THE DEVICE WAS RETRIEVED OUT OF THE SHEATH, IT WAS FOUND THE CATHETER KINK AND RADIOPAQUE MARKERS DISTAL SIDE RUPTURED. ANOTHER VBHR101002W WAS UTILIZED TO COMPLETE THE PROCEDURE. ON SEP 9, 2024, RECEIVED PHOTO FROM HISTOLOGY, IT SHOWED THE CATHETER WAS SEPARATED NEAR TRANSITION BUT CONNECTING WITH DEPLOYMENT LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622378 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male