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

Catalog Number	BXA075902A
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
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: device remains implanted, and no images were provided.Therefore, direct product analysis was not possible.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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
The following was received from a clinical study: on (b)(6) 2020, a study patient underwent a aaa procedure and a tambe device was implanted.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were used as branched devices in the visceral arteries.During a 48-month follow-up on (b)(6) 2024, cta images were completed.A wire fracture of the tambe aortic component was observed.The fracture appeared to be the first stent row distal to the right renal artery portal and is posterior in nature.Other observations reported were: vbx device ovalization of the right renal artery side branch component within the aorta just distal to the portal gold ring.Vbx device ovalization of the celiac artery side branch component within the aorta just proximal of the celiac artery origin.As reported, the branch devices remain patent.No intervention was reported or planned for the device ovalizations.
Additional Manufacturer Narrative
B3: event date was corrected.B5: event description was corrected.
Event or Problem Description
A study alert from a clinical study was received: on (b)(6) 2020, a a study patient underwent a aaa procedure and a tambe device was implanted.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were used as branched devices in the visceral arteries.During a 48-month follow-up on (b)(6) 2024, cta images were completed.Observation stated vbx device ovalization of the right renal artery side branch component within the aorta just distal to the portal gold ring.Vbx device ovalization of the celiac artery side branch component within the aorta just proximal of the celiac artery origin.

• 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: 21293844
• Report Number: 2017233-2025-05791
• Device Sequence Number: 12730551
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: (01)00733132637294(17)230226
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2023
• Device Catalogue Number: BXA075902A
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White