BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 19143447 · Received April 19, 2024

    Report

    Report Number
    2017233-2024-04852
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 24, 2024
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A2/A3/A4 PATIENT INFORMATION WILL NOT BE MADE AVAILABLE BY THE SITE. H3: OTHER CODE: THE DEVICE IS AVAILABLE, BUT WAS NOT RETURNED FOR FURTHER INVESTIGATION 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. 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. 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

    B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED. THE REPORTED FAILURE MODE OF STUCK DEPLOYMENT LINE IS CONSISTENT WITH THE FINDINGS OF INABILITY TO DEPLOY BY PULLING ON THE KNOB DURING ENGINEERING EVALUATION. THE KNOT PRESENT IN THE DEPLOYMENT LINE IS LIKELY THE CAUSE OF INABILITY TO DEPLOY DURING ENGINEERING EVALUATION. HOWEVER, NEITHER THE TIMING, NOR ROOT CAUSE OF THE KNOT PRESENT IN DEPLOYMENT LINE CAN BE ESTABLISHED WITH THE AVAILABLE INFORMATION, LEADING TO INABILITY TO DETERMINE ROOT CAUSE OF STUCK DEPLOYMENT LINE DURING PROCEDURE. THE DEVICE, AS RETURNED, HAD PARTIAL DEPLOYMENT OF THE OUTER ZIPPER PAST THE REGION OF THE KNOT IN DEPLOYMENT LINE. IT WAS AN OVERHAND KNOT. THE REPORTED INABILITY TO DEPLOY WITH NO DEVICE EXPANSION WAS CONFIRMED DURING EVALUATION OF THE RETURNED VIABAHN® DEVICE. THE CONDITION OF THE DEVICE AS RETURNED EXHIBITED PARTIAL OUTER ZIPPER DEPLOYMENT, AND A KNOT IN THE DEPLOYMENT LINE WAS NOTED NEAR THE TRANSITION. DEPLOYMENT COULD NOT BE CONTINUED AT THE KNOB OR BY APPLYING TRACTION AT THE ENDOPROSTHESIS PROXIMAL TO THE LOCATION OF THE KNOT. DEPLOYMENT WAS RESUMED WITH TRACTION DISTAL TO THE LOCATION OF THE KNOT, INDICATING THE SOURCE OF THE DEPLOYMENT DIFFICULTY DURING EVALUATION WAS ATTRIBUTED TO THE PRESENCE OF THE KNOT. HOWEVER, NEITHER THE TIMING OF OCCURRENCE NOR CAUSE OF THE KNOT COULD BE DETERMINED, AND IT IS UNKNOWN WHETHER THE KNOT WAS PRESENT DURING THE REPORTED DEPLOYMENT FAILURE AS OBSERVED WITHIN THE FIELD. ADDITIONALLY, AS REPORTED FROM THE FIELD, ADDITIONAL MANIPULATION WAS PERFORMED TO ATTEMPT TO DEPLOY THE DEVICE IN VITRO FOLLOWING WITHDRAWAL FROM THE PATIENT. THEREFORE, THE CONDITION OF THE RETURNED DEVICE IS NO LONGER REPRESENTATIVE OF ITS CONDITION AT THE REPORTED INSTANCE DURING WHICH FAILURE WAS INITIALLY OBSERVED. PROCEDURAL AND BENCHTOP 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 ROOT CAUSE OF THE OBSERVED PARTIAL DEPLOYMENT WITH STUCK DEPLOYMENT LINE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION, INCLUDING DEVICE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A SUBCLAVIAN ARTERY DEBRANCHING WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) AFTER TREATMENT OF THE AORTIC ARCH WITH A THORACIC STENTGRAFT. IT WAS STATED THAT AFTER PULLING THE DEPLOYMENT LINE, THE VSX-DEVICE DID NOT OPEN, NOT EVEN PARTIALLY. THE PHYSICIAN HAD TO REMOVE THE WHOLE DELIVERY SYSTEM AND USED ANOTHER VSX-DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. A 260 CM TERUMO ADVANTAGE GUIDE WIRE AND A 12 FR OSCOR STEERABLE SHEATH WAS USED. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A SUBCLAVIAN ARTERY DEBRANCHING WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) AFTER TREATMENT OF THE AORTIC ARCH WITH A THORACIC STENTGRAFT. THE ANATOMY OF THE PATIENT WAS REPORTED TO BE "STANDARD". IT WAS STATED THAT AFTER PULLING THE DEPLOYMENT LINE IT GOT STUCK AND THE VSX-DEVICE DID NOT OPEN, NOT EVEN PARTIALLY. THE PHYSICIAN HAD TO REMOVE THE WHOLE DELIVERY SYSTEM AND USED ANOTHER VSX-DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. A 260 CM TERUMO ADVANTAGE GUIDE WIRE WITH UNKNOWN DIAMETER AND A 12 FR OSCOR STEERABLE SHEATH WAS USED. IT WAS STATED THAT THE DELIVERY CATHETER WAS HELD STRAIGHT DURING DEPLOYMENT OF THE DEVICE AND THAT AFTER REMOVAL OF THE DEVICE FROM THE PATIENT, THE OR STAFF TRIED TO DEPLOY THE DEVICE ON A SIDE TABLE WITHOUT SUCCESS. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686657 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 Required Intervention 260 CM TERUMO ADVANTAGE GUIDE WIRE12 FR OSCOR ST