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

Catalog Number	BXB073901A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent treatment for plaque in the abdominal aorta using a gore® excluder® aaa endoprosthesis where a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used in the left common iliac artery.It was reported the patient returned to the hospital on (b)(6) 2025, with worsening pain and new numbness in the foot.A ct scan revealed thrombosis on left limb, prompting a thrombectomy procedure.At this time, the physician implanted three additional vbx devices to reinforce both limbs up the gore® excluder® aaa endoprosthesis bifurcation.A final angiogram was performed and everything looked patent.Additionally, an intravascular ultrasound (ivus) was performed on both limbs, with results showing no abnormalities.Physician suspected the issue was possibly due to post dilation after initial procedure, with the right limb exerting pressure on the left limb.The patient is currently doing well.
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: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6 ¿ code b20: device remains implanted, and no images were provided; therefore, direct product analysis was not possible.Engineering evaluation: the primary reported complaint could not be independently confirmed because there were no items returned for evaluation.The cause for the reported vbx device compression and associated thrombosis cannot be determined with the available information.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.

• 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: jazmin dela rosa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21885914
• Report Number: 2017233-2025-06097
• Device Sequence Number: 19720959
• Product Code: PRL
• UDI-Device Identifier: 00733132658633
• UDI-Public: (01)00733132658633(17)270912
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/22/2025

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: BXB073901A
• 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: 04/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2024
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male