MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number	BXB073902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: the device(s) remain implanted; therefore, direct product analysis was not possible.A4: patient weight was requested, but not made available.Manufacturing report #2017233-2025-05939 was also submitted for same patient/same procedure and intervention.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.
Event or Problem Description
On (b)(6) 2025, patient underwent an endovascular procedure (gore® excluder® thoracoabdominal branch endoprosthesis) was implanted to treat an aneurysm.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) were implanted as branch devices.Two vbx devices were implanted in the right renal artery.On (b)(6) 2025 post-procedure, ct imaging showed thrombosed vbx stents in the right renal artery (rra).Distal dissection was also noted.Implanted most distally in the rra was the 6 x79 vbx stent.An intervention was performed.After the thrombectomy, a bare metal stent was implanted for a 2cm distal extension.For radial strength, the existing vbx stents were relined with implantation of a new 7x79 vbx device.As reported, the cause of thrombosis is unknown; however, physician stated the occlusion could be related to the rra dissection.There were no issues noted during the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6 - code b15: imaging was provided and evaluation states: two time-points were available for evaluation: pre-implantation cta dated (b)(6)2024 and post-implantation cta dated (b)(6)2025.Pre-implantation cta image scene shows right renal artery (rra) diameters appear to range from ~4.1mm ¿ 7.5mm (proximal).Cannot confirm without dicom imaging.Post-implantation cta dated (b)(6)2025 shows: oblique 3d images show a steep angulation into the rra.The length of the devices implanted in the rra appears to be ~9.9cm, by outer curve length.The amount of stent overlap appears to be ~1cm, by outer curve length.The length of the first (proximal) implanted stent in the rra appears to be ~3.6cm, by outer curve length.(bxb073902a).The length of the distal stent implanted in the rra appears to be ~7.4cm, by outer curve length.(bxb067902a).A 3d image shows a steep angulation into the lsa.The length from the lsa ostium to the first branch appears to be ~3.1cm, by centerline.Lsa diameters appear to range from ~7.3mm - 11.7mm (proximal).Reconstruction images show a dissection at the level of the proximal lsa.The tear is located ~1.6mm proximal to the distal lsa border.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21613118
• Report Number: 2017233-2025-05940
• Device Sequence Number: 20721396
• Product Code: PRL
• UDI-Device Identifier: 00733132658640
• UDI-Public: (01)00733132658640(17)270925
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BXB073902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/15/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female