BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 21796359 · Received April 8, 2025

    Report

    Report Number
    2017233-2025-06040
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 11, 2025
    Report Date
    December 19, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. H6 INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. IF THE DELIVERY CATHETER IS AVAILABLE AND WILL BE RETURNED, THEN AN ENGINEERING INVESTIGATION WILL BE PERFORMED. IN ADDITION, FURTHER DETAILS WERE REQUESTED BUT WERE NOT PROVIDED YET. 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.

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED. BASED ON INVESTIGATION OF THE COMPLAINT, THE VBX DEVICE CATHETER BROKE OUTSIDE OF THE PATIENT. THEREFORE, THE INCIDENT DOES NOT MEET THE DEFINITION OF A REPORTABLE SERIOUS INJURY OR REPORTABLE MALFUNCTION. THIS MALFUNCTION IS NOT EXPECTED TO LEAD DIRECTLY OR INDIRECTLY TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. FOR THESE REASONS, THIS EVENT IS CONSIDERED NOT REPORTABLE AND MANUFACTURER REPORT # 2017233-2025-06040 IS BEING RETRACTED.

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION: THE FAILURE MODE OF A BROKEN DELIVERY CATHETER SHAFT WAS CONFIRMED AS THE HUB AND SHRINK SLEEVE WERE RETURNED DETACHED FROM THE CATHETER WITH PEBAX IN THE HUB, INDICATING A BREAK IN THE CATHETER SHAFT RATHER THAN A BOND FAILURE IN THE COMPONENTS. THE CAUSE OF THE BROKEN CATHETER SHAFT IS UNKNOWN. AN ATTEMPT AT REPLICATING THE INCIDENT TO FURTHER UNDERSTAND THE FAILURE WAS NOT PURSUED BECAUSE THE STATE OF THE DEVICE IS NO LONGER REPRESENTATIVE OF HOW IT WOULD HAVE BEEN RECEIVED BY THE USER. THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE REPORTED PRIMARY DEVICE FAILURE MODE CONCERNING WITHDRAWAL DIFFICULTY OF THE DELIVERY SYSTEM CATHETER COULD NOT BE INDEPENDENTLY CONFIRMED AS THE CLINICAL CONDITIONS THAT MAY INFLUENCE DEVICE WITHDRAWAL COULD NOT BE REPLICATED IN A LABORATORY SETTING. CATHETER DAMAGE, INCLUDING KINKING AND NECKING, AND SEPARATION OF THE DUAL LUMEN CATHETER AT THE SHRINK SLEEVE WERE OBSERVED AND ARE CONSISTENT WITH WITHDRAWAL DIFFICULTY AS REPORTED. HOWEVER, THE ROOT CAUSE OF THE WITHDRAWAL DIFFICULTY COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THE REPORTED BROKEN COMPONENTS FAILURE MODE WAS CONFIRMED DURING EVALUATION OF THE RETURNED DEVICE. THE DUAL LUMEN CATHETER WAS RETURNED WITH THE HUB ASSEMBLY AND ATTACHED SHRINK SLEEVE SEPARATED FROM THE CATHETER AT THE JUNCTION OF THE CATHETER-SHRINK SLEEVE INTERFACE. REMNANTS OF BLUE CATHETER MATERIAL WITHIN THE HUB ASSEMBLY INDICATED A PULL FORCE WAS APPLIED WITH RUPTURE OF THE CATHETER SHAFT. THE FIELD INDICATED RESISTANCE WAS FELT DURING WITHDRAWAL ATTEMPT OF THE BALLOON CATHETER THROUGH A SHEATH, AND COMPONENTS SEPARATED WHILE THE USER APPLIED MORE FORCE TO THE DELIVERY CATHETER. THEREFORE, THE ROOT CAUSE OF THE OBSERVED BROKEN CATHETER SHAFT IS CONSISTENT WITH REASONABLY FORESEEABLE MISUSE, SPECIFICALLY USER APPLIES EXCESSIVE FORCE TO THE DELIVERY SYSTEM (LEADING TO EXTENSIVE TENSILE LOAD, TWISTING, OR TORSION LOAD AND COMPROMISED/BROKEN DELIVERY SYSTEM). THE IFU WARNS AGAINST THE USE OF EXCESSIVE FORCE DURING WITHDRAWAL OF THE DELIVERY SYSTEM TO PREVENT DAMAGE TO THE DELIVERY CATHETER. THE IFU FURTHER STATES TO REFRAIN FROM FORCING REMOVAL IF RESISTANCE IS ENCOUNTERED DURING WITHDRAWAL OF THE DELIVERY SYSTEM. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), FOR THE APPROPRIATE REGION AND TIME-PERIOD, WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL AND THERE ARE APPLICABLE STATEMENTS. THE IFU STATES THE FOLLOWING: ¿IF RESISTANCE IS ENCOUNTERED UPON ATTEMPTED REMOVAL, DO NOT FORCE REMOVAL, USE FLUOROSCOPY AND CONVENTIONAL TECHNIQUES TO DETERMINE AND REMEDY THE CAUSE OF RESISTANCE BEFORE PROCEEDING.¿ THE IFU ALSO STATES: ¿EXCESSIVE OR ABRUPT FORCE DURING CATHETER REMOVAL MAY DAMAGE THE DELIVERY CATHETER OR INTRODUCER SHEATH.¿

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PERIPHERAL ARTERY DISEASE (PAD) IN THE PELVIS USING A COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) PROCEDURE. IT WAS STATED THAT THE STENOSIS IN THE DISTAL AORTA WAS TREATED WITH AN AORTIC BEGRAFT AND THE STENOSES IN THE PELVIS ON BOTH SIDES WERE TREATED EACH WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE, BXA117902E). AN 8 FR ARROW SHEATH AND A 0.035-INCH AMPLATZ SUPER STIFF WIRE WERE USED ON THE RIGHT SIDE. AFTER THE SUCCESSFUL DEPLOYMENT OF THE VBX DEVICE ON THE RIGHT SIDE, THE CATHETER HEAD TORE OFF AFTER THE DEFLATED BALLOON WAS PULLED BACK THROUGH THE SHEATH. THE VBX BALLOON AND CATHETER WERE COMPLETELY REMOVED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PERIPHERAL ARTERY DISEASE (PAD) IN THE PELVIS USING A COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) PROCEDURE. IT WAS STATED THAT THE STENOSIS IN THE DISTAL AORTA WAS TREATED WITH AN AORTIC BEGRAFT AND THE STENOSES IN THE PELVIS ON BOTH SIDES WERE TREATED EACH WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE, BXA117902E). AN 8 FR ARROW SHEATH AND A 0.035-INCH AMPLATZ SUPER STIFF WIRE WERE USED ON THE RIGHT SIDE. AFTER THE SUCCESSFUL DEPLOYMENT OF THE VBX DEVICE ON THE RIGHT SIDE, RESISTANCE WAS FELT DURING WITHDRAWAL AND EXTRA FORCE WAS APPLIED TO REMOVE THE CATHETER. FINALLY THE CATHETER HEAD TORE OFF AFTER THE DEFLATED BALLOON WAS PULLED BACK THROUGH THE SHEATH. THE VBX BALLOON AND CATHETER WERE COMPLETELY REMOVED. THE PATIENT WAS DOING WELL. IT WAS STATED THAT THE LESION WAS VERY CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754388 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention