BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20020774 · Received August 21, 2024

    Report

    Report Number
    2017233-2024-05243
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 9, 2024
    Report Date
    November 7, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 W. L. GORE INTERNAL CASE NUMBER. H3: OTHER CODE: AS THE MEDICAL DEVICE WAS DISCARDED ON SITE, NO INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR EVALUATION. 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. THE PHYSICIAN STATED THAT A POSSIBLE ROOT CAUSE IS THE PROFILE OF THE OLIVE. WITH THE INFORMATION PROVIDED TO GORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED. 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

    INVESTIGATION SUMMARY: THE PRIMARY COMPLAINT OF VSX DEVICE DISTAL SHAFT SEPARATION WAS CONFIRMED. A PHOTO PROVIDED SHOWS THE DISTAL SHAFT SEPARATED FROM THE VSX DEVICE CATHETER AT THE TRANSITION. THE VSX DEVICE ITSELF WAS REPORTEDLY DISCARDED AND WAS THEREFORE UNAVAILABLE FOR EVALUATION. IT WAS REPORTED THAT THE DISTAL TIP ¿STOPPED AT THE INTRODUCER SHEATH ENTRY¿ DURING WITHDRAWAL. DUE TO THE POTENTIAL FOR DAMAGE TO THE ENDOPROSTHESIS, DELIVERY CATHETER, OR INTRODUCER SHEATH, THE VSX DEVICE INSTRUCTIONS FOR USE PROVIDE SPECIAL INSTRUCTIONS TO AID IN RELEASE OF THE VSX DEVICE IF RESISTANCE IS ENCOUNTERED DURING WITHDRAWAL. THE ROOT CAUSE OF THE DISTAL SHAFT SEPARATION IS CONSISTENT WITH THE POTENTIAL USE ERROR OF FORCEFUL WITHDRAWAL OF THE VSX DEVICE. THE VSX DEVICE IFU WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD, AND THE FOLLOWING IFU STATEMENTS WERE IDENTIFIED AS RELATED TO THE FAILURE MODE(S) IN THIS COMPLAINT: "WHILE MAINTAINING THE POSITION OF THE GUIDEWIRE ACROSS THE TREATED LESION, CAREFULLY WITHDRAW THE DELIVERY CATHETER THROUGH THE LUMEN OF THE ENDOPROSTHESIS AND REMOVE IT VIA THE INTRODUCER SHEATH. MODERATE RESISTANCE MAY BE FELT WHEN THE DISTAL TIP EXIT THROUGH THE HEMOSTASIS VALVE OF THE INTRODUCER SHEATH. NOTE: IF, DURING CATHETER REMOVAL, THE CATHETER TIP CATCHES ON THE EDGE OF THE ENDOPROSTHESIS, A SLIGHT ¿BACK AND FORTH¿ MOTION OF THE CATHETER MAY AID IN RELEASE."

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ANEURYSM WITH A COOK CUSTOM DEVICE AS MAIN BODY AND WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) AS BRANCH DEVICE FOR THE SUPERIOR MESENTERIC ARTERY (SMA). IT WAS STATED THAT AFTER DEPLOYMENT OF THE VSX-DEVICE AND DURING REMOVAL OF THE DELIVERY SYSTEM, THE OLIVE STOPPED AT THE INTRODUCER SHEATH ENTRY AND BROKE OFF. THE PHYSICIAN WAS ABLE TO CAPTURE THE OLIVE WITH THE ROZEN GUIDEWIRE AND BROUGHT ALL PARTS BACK INTO THE 8 FR SHEATH AND REMOVED BOTH, OLIVE AND DELIVERY SYSTEM, OUTSIDE THE PATIENT. 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 AN AORTIC ANEURYSM WITH A COOK CUSTOM DEVICE AS MAIN BODY AND WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) AS BRANCH DEVICE FOR THE SUPERIOR MESENTERIC ARTERY (SMA). IT WAS STATED THAT A 0.035" STIFF ROSEN GUIDEWIRE WAS USED, THAT THE CATHETER WAS NOT HELD STRAIGHT AND THE PHYSICIAN CONSIDERED THIS A STANDARD SMA. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE VSX-DEVICE AND DURING REMOVAL OF THE DELIVERY SYSTEM, THE OLIVE STOPPED AT THE INTRODUCER SHEATH ENTRY AND BROKE OFF. AS THE OLIVE WAS STILL ON THE GUIDEWIRE, THE PHYSICIAN WAS ABLE TO RECOVER THE OLIVE WITH THE 8 FR INTRODUCER SHEATH AND REMOVED BOTH, OLIVE AND DELIVERY SYSTEM, OUTSIDE THE PATIENT. THE PHYSICIAN REPORTED THAT NO GREATER THAN THE NORMAL RETRACTION FORCE WAS APPLIED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128249 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other ROZEN GUIDEWIRE