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

Catalog Number	BXB085902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Rupture (2208)
Date of Event	06/03/2025
Type of Reportable Event	Death
Event or Problem Description
The following information was reported from the (b)(4) clinical study manager: on (b)(6) 2025, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.The maximum diameter of the aortic disease was 67mm.Two gore® viabahn® vbx balloon expandable endoprosthesis devices were implanted in the patient's celiac artery.It was reported that, during the procedure, the patient experienced a splenic artery rupture.The physician attempted to repair the rupture, but ultimately a splenectomy was performed.The patient tolerated the procedure.Reportedly, the patient experienced complications post procedure, including liver shock, and continued to decline.The patient was placed on comfort care.On (b)(6) 2025, the patient expired.During the autopsy on (b)(6) 2025, the site explanted the tambe device system.The explanted device system was returned.It was noted that the device explant was not reportedly related to an allegation against the device system, but that the explant was performed during the already planned autopsy procedure.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog # bxb095902a/ serial #( b)(6)/ udi #(b)(4) as a component of the same system.Catalog # ataa43720160a/ serial # (b)(6)/ udi # (b)(4).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
H.6.Investigation findings for analysis of production records: code c21 updated to code c19 h.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings for testing of actual/suspected device (explant evaluation): code c21 remains unchanged.H.6.Investigation conclusions: code d16 remains unchanged.
Additional Manufacturer Narrative
Retraction of manufacturer report number 2017233-2025-06381.After further review, it was determined this is a non-reportable complaint.The vbx device did not cause or contribute to the patient death.The death did not occur intra-procedure and evidence does not suggest the vbx device caused or contributed to the death.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22399009
• Report Number: 2017233-2025-06381
• Device Sequence Number: 4799325
• Product Code: PRL
• UDI-Device Identifier: 00733132658749
• UDI-Public: (01)00733132658749(17)280308
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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: BXB085902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 09/24/2025; Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2025
• 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: Death; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White