BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 16269022 · Received January 30, 2023

    Report

    Report Number
    2017233-2023-03672
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 16, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132637744
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. PATIENT WEIGHT WAS REQUESTED, BUT NOT MADE AVAILABLE. DEVICE EVALUATED BY MFR: DEVICE WAS DISCARDED AT USER FACILITY. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ENGINEERING EVALUATION WAS CONDUCTED: THE PRIMARY REPORTED DEVICE FAILURE MODE, RELATED TO DEVICE MIGRATION, COULD NOT BE INDEPENDENTLY CONFIRMED BECAUSE NEITHER IMAGES NOR THE DEVICE WERE RETURNED FOR EVALUATION. THE REPORTED INFORMATION INDICATES THE DEVICE, USED TO TREAT VENOUS OCCLUSIVE DISEASE, WAS USED IN AN OFF-LABEL MANNER. THE CAUSE FOR THE REPORTED DEVICE MIGRATION AFTER DEPLOYMENT IS CONSIDERED TO BE RELATED TO OFF-LABEL USE OF THE DEVICE IN A VENOUS APPLICATION. (B)(4). IFU FOR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS INTENDED USE / INDICATIONS STATE: THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IS INDICATED FOR THE TREATMENT OF DE NOVO OR RESTENOTIC LESIONS FOUND IN ILIAC ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 5 MM - 13 MM AND LESION LENGTHS UP TO 110 MM, INCLUDING LESIONS AT THE AORTIC BIFURCATION. SIZING AND SELECTION OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO PREVENT ENDOPROSTHESIS MIGRATION, CARE SHOULD BE TAKEN TO ENSURE THE DEVICE IS SUFFICIENTLY APPOSED TO THE VESSEL WALL BETWEEN INITIAL DEVICE DEPLOYMENT AND POST-DILATATION (IF PERFORMED). 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

    MANUFACTURER REPORT #2017233-2023-03672 IS BEING RETRACTED AFTER RE-ASSESSMENT. THIS COMPLAINT WAS DEEMED NON-REPORTABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TREATED FOR STENOSIS OF THE BRACHIOCEPHALIC VEIN / SUPERIOR VENA CAVA (SVC) THAT MEASURED APPROXIMATELY 5-6MM BY UTILIZING AN IVUS AS REPORTED, SEVERAL OPTIONS WERE CONSIDERED, BUT DUE TO THE RISK OF RUPTURE, THE PHYSICIAN ELECTED TO IMPLANT A COVERED STENT. AFTER CTA ANALYSIS AND SUBSEQUENT VENOGRAMS, AN 11 X 59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS SELECTED. FROM THE RIGHT FEMORAL VEIN ACCESS, THE VBX DEVICE WAS PLACED VIA 8FR PINNACLE SHEATH INTO THE RIGHT BRACHIOCEPHALIC VEIN /PROXIMAL SVC JUNCTION. PLACEMENT WAS CONFIRMED AND VBX BALLOON WAS INFLATED TO NOMINAL PRESSURE AND THEN TO RBP OF 12ATM UNDER FLUOROSCOPY. BALLOON DEFLATION WAS FLUOROSCOPICALLY VERIFIED. VBX BALLOON WAS REMOVED OVER THE WIRE IN ORDER TO POST DILATE THE VBX STENT TO 16MM USING ANOTHER BALLOON. STENT POSITION WAS CHECKED AGAIN AND IT WAS NOTICED THE VBX STENT HAD MIGRATED ON THE WIRE INTO THE RIGHT ATRIUM OF THE HEART. THE 8FR SHEATH WAS SWITCHED FOR AN INARI 20FR SHEATH TO ALLOW FOR OTHER MODALITIES TO STABILIZE AND RETRIEVE THE MIGRATED VBX STENT. WHILE MAINTAINING THROUGH AND THROUGH WIRE ACCESS, A 15-30MM ENSNARE DEVICE WAS USED TO RETRIEVE THE VBX STENT FROM THE RIGHT ATRIUM INTO THE RIGHT FEMORAL VEIN. A COMBINATION OF SEVERAL LARGER DIAMETER ATLAS BALLOONS, ON A SEPARATE BUDDY WIRE, WAS THEN USED TO CRUSH/FOLD THE VBX STENT IN THE RIGHT ILIAC VEIN. WHILE MAINTAINING SNARE CAPTURE, THE VBX STENT WAS MOVED INTO THE 20FR SHEATH. EVERYTHING WAS REMOVED AND MULTIPLE VENOGRAMS CONFIRMED THERE WAS NO VESSEL RUPTURE OR PATIENT HARM. THE PHYSICIAN SUSPECTS WHAT CAUSED OR CONTRIBUTED TO THE DEPLOYED STENT MIGRATION WAS LACK OF BILATERAL SUPPORT AS THE OTHER SIDE WAS NOT BALLOONED OR STENTED IN A KISSING FASHION. USING A KISSING TECHNIQUE, MEDTRONIC-ABRE STENTS VIA DUAL ACCESS IN RIGHT FEMORAL VEIN AND LEFT BRACHIOCEPHALIC VEIN WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619916 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. BXA115902A 00733132637744

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female