BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 17368505 · Received July 20, 2023

    Report

    Report Number
    2017233-2023-04132
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 7, 2023
    Report Date
    September 28, 2023
    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

    H10: C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE MANUFACTURING SPECIFICATIONS. THE REPORTED DEVICE FAILURE MODE, PARTIAL EXPANSION WITH THE INABILITY TO COMPLETE FULL EXPANSION OF THE ENDOPROSTHESIS, COULD NOT BE CONFIRMED THROUGH EVALUATION OF THE RETURNED DEVICE. THE DEVICE WAS RETURNED WITH NEITHER THE ENDOPROSTHESIS NOR THE DISTAL SHAFT. THE RETURNED DEVICE INCLUDED THE PROXIMAL END OF THE DELIVERY SYSTEM UP TO THE TRANSITION. THE DISTAL SHAFT AND DISTAL TIP WERE NOT RETURNED. THIS CONFIRMS THE REPORTED BROKEN DELIVERY CATHETER. DAMAGES TO THE DELIVERY SYSTEM OBSERVED DURING EVALUATION, INCLUDING THE MISSING DISTAL SHAFT, COLUMNAR FAILURE, FLATTENING OF THE TRANSITION COMPONENT, AND A BROKEN DEPLOYMENT LINE ARE CONSISTENT WITH BOTH THE DEVICE MANIPULATION DURING THE PROCEDURE WHILE ATTEMPTING TO OVERCOME THE REPORTED PARTIAL ENDOPROSTHESIS EXPANSION AND THE WITHDRAWAL FORCE APPLIED THAT LED TO THE DELIVERY SYSTEM BREAKING. PROCEDURAL DEPLOYMENT OF THE DEVICE CAN BE IMPACTED BY DIFFERENT FACTORS INCLUDING BUT NOT LIMITED TO ZIPPER INTEGRITY AND/OR DELIVERY SYSTEM SUPPORT OR STIFFNESS. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED ISSUE.

    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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS IMPLANTED WITH 7MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO TREAT THE ENTRY OF RENAL ARTERY DURING THE ABDOMINAL AORTIC DISSECTION PROCEDURE. THE VIABAHN DEVICE WAS ADVANCED VIA 8FR XIANJIAN SHEATH TO TARGET LESION. THEN THE PHYSICIAN PULLED OUT DEPLOYMENT KNOB TO DEPLOY THE DEVICE. THE DISTAL ENDOPROSTHESIS WAS SUCCESSFULLY EXPANDED. THE PROXIMAL ENDOPROSTHESIS COULDN'T BE EXPANDED. THE HALF ENDOPROSTHESIS WASN'T EXPANDED AFTER HALF AN HOUR. THE VIABAHN DEVICE COULDN'T BE WITHDRAWN AS THE DISTAL OF ENDOPROSTHESIS WAS STUCK IN THE VESSEL TIGHTLY. DURING THE REMOVAL, THE CATHETER WAS BROKEN. THE PHYSICIAN TRIED TO USE SNARE TO REMOVE PARTIALLY EXPANDED ENDOPROSTHESIS AND SEPARATED CATHETER. ANGIOGRAPHY SHOWED THAT THE STENT WAS LOCATED WITHIN THE LEFT RENAL ARTERY WITHOUT BLOOD FLOW INTO THE LEFT RENAL ARTERY. THE BLOOD FLOW IN THE LEFT RENAL ACCESSORY RENAL ARTERY WAS GOOD. THE PROCEDURE WAS ENDED, AND THE PATIENT WAS UNDER CONTINUOUS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975721 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male