BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 20290512 · Received September 24, 2024

    Report

    Report Number
    2017233-2024-05337
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 9, 2024
    Report Date
    November 14, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE CASE NUMBER. H3 OTHER: THE DEVICE IS AVAILABLE, BUT WAS NOT RECEIVED YET. H6 EVALUATION CODES INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. AFTER RECEIPT OF THE DEVICE, AN ENGINEERING INVESTIGATION WILL BE CONDUCTED. FURTHER INVESTIGATION IS BEING CONDUCTED AND WILL BE INCLUDED IN THE FINAL REPORT. 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. 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

    ENGINEERING EVALUATION: THIS COMPLAINT WAS INITIATED ON THE BASIS OF INFORMATION RECEIVED FROM THE FIELD. THE INFORMATION REPORTED IN THE COMPLAINT INDICATES THE USER EXPERIENCED AN INABILITY TO DEPLOY THE DEVICE WITH BOWSTRINGING OF THE ENDOPROSTHESIS, THERE WAS NO EXPANSION OF THE ENDOPROSTHESIS, AND THE DEVICE WAS SUBSEQUENTLY WITHDRAWN WITHOUT ADDITIONAL COMPLICATION. THE VIABAHN® DEVICE WAS RETURNED TO GORE FOR EVALUATION, AND DEPLOYMENT OF THE INNER ZIPPER HAD NOT BEEN INITIATED. THE EVALUATION HAS OBSERVED THE DEPLOYMENT MECHANISM TO BE FUNCTIONAL: THE DEPLOYMENT LINE WAS NOT CAUGHT ON ANY PART OF THE DEVICE AND DEPLOYMENT CONTINUED DURING EVALUATION. NO BOWSTRINGING WAS OBSERVED DURING EVALUATION. THE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTY COULD NOT BE ESTABLISHED. 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 INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR THE PRIMARY DEVICE FAILURE MODE POTENTIALLY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE, THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR CONNECTING AN INNER BRANCH OF A CUSTOM-MADE TERUMO THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) DEVICE TO THE LEFT SUBCLAVIAN ARTERY WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS STATED THAT ACCESS WAS CREATED THROUGH THE RIGHT COMMON FEMORAL ARTERY. TRAJECT FROM RIGHT COMMON FEMORAL ARTERY TO LEFT SUBCLAVIAN ARTERY WAS LONG AND TORTUOUS. THE PHYSICIAN USED A 10 FR SHEATH. AS IT WAS NOT POSSIBLE TO GET A LONG 10 FR SHEATH ACROSS, HE DECIDED TO USE A SHORT 10 FR SHEATH AND PUSHED UP THE VIABAHN DEVICE BARE (UNPROTECTED) TOWARDS THE LEFT SUBCLAVIAN ARTERY. NEVERTHELESS, THE PHYSICIAN DID NOT FEEL ABNORMAL RESISTANCE WHILE MOVING THE DEVICE UP. IT WAS REPORTED THAT ONCE THE DEVICE WAS IN POSITION, THE DOCTOR PULLED THE DEPLOYMENT LINE OF THE VIABAHN DEVICE WHILE HOLDING THE DELIVERY CATHETER STRAIGHT. SOMEHOW, HE FELT RESISTANCE WHILE DEPLOYING AND THE DEVICE WENT TO A C-SHAPE (BOWSTRINGING). THE DOCTOR DIDN¿T DARE TO FURTHER DEPLOY THE DEVICE AND DECIDED TO REMOVE IT. ANOTHER 2 VIABAHN DEVICES (13 X 05) WERE USED AND WERE IMPLANTED IN THE LEFT SUBCLAVIAN ARTERY WITHOUT ANY PROBLEMS. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290104 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other