BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 20924824 · Received December 13, 2024

    Report

    Report Number
    2017233-2024-05596
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 27, 2024
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER; H6 CODE B21, C21: THE MEDICAL DEVICE RETURNED TO GORE. PRODUCT EVALUATION IS CURRENTLY CONDUCTED. H6 CODE B14, C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H3 OTHER; H6 CODE B01, C19, D15: PRODUCT INVESTIGATION REPORT CONCLUSION: THE REPORTED PRIMARY FAILURE MODE, RELATED TO A BROKEN CATHETER DURING WITHDRAWAL, WAS CONSISTENT WITH THE ENGINEERING EVALUATION FINDINGS OF THE DISTAL SHAFT BEING SEPARATED FROM THE DUAL LUMEN CATHETER. THE ROOT CAUSE OF THE REPORTED PRIMARY FAILURE MODE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    C1: CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H3 OTHER; H6 CODE B17, C21: THE MEDICAL DEVICE IS IN TRANSITION TO GORE. H6 CODE B14, C21: THE INVESTIGATION IS ONGOING. PRELIMINARY RESULTS ARE NOT YET AVAILABLE. 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 71-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED SUCCESSFULLY FOR THE TREATMENT OF A POPLITEAL ARTERY ANEURYSM. THE CATHETER WAS BROKEN AFTER THE DEPLOYMENT. THE BREAKAGE OCCURRED AFTER THE PROSTHESIS WAS RELEASED, DURING RETRACTION WHILE STILL IN THE PATIENT. THE BROKEN PART REMAINED ON THE GUIDEWIRE (UNKNOWN MANUFACTURER) AND COULD BE OBTAINED EASILY AND SAFELY FOR THE PATIENT. THE CATHETER IS BROKEN AT THE PROXIMAL TRANSITION, WHERE THE NARROW PART MERGES BACK INTO THE THICK CATHETER. THE VIABAHN DEVICE ITSELF WAS IMPLANTED SUCCESSFULLY AND NO CORRECTIONS WERE NECESSARY TO THE POSITION OF THE VIABAHN DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 71-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED SUCCESSFULLY FOR THE TREATMENT OF A POPLITEAL ARTERY ANEURYSM. THE CATHETER WAS BROKEN AFTER THE DEPLOYMENT. THE BREAKAGE OCCURRED AFTER THE PROSTHESIS WAS RELEASED, DURING RETRACTION WHILE STILL IN THE PATIENT. THE BROKEN PART REMAINED ON THE GUIDEWIRE AND COULD BE OBTAINED EASILY AND SAFELY FOR THE PATIENT. THE CATHETER IS BROKEN AT THE PROXIMAL TRANSITION, WHERE THE NARROW PART MERGES BACK INTO THE THICK CATHETER. THE VIABAHN DEVICE ITSELF WAS IMPLANTED SUCCESSFULLY AND NO CORRECTIONS WERE NECESSARY TO THE POSITION OF THE VIABAHN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407511 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male