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

Catalog Number	BXA067902A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a study patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprostheses (tambe) and gore® viabahn® vbx balloon expandable endoprostheses (vbx devices) were implanted in the visceral arteries as branch devices.Two vbx devices were implanted in an overlapped fashion as one unit in the left renal artery.On (b)(6), 2021, an additional vbx device (bxa067902a) was implanted in the left renal artery as a second distal extension in a post-treatment procedure.During patient's follow-up on (b)(6) 2023, it was observed a stenosis had developed at the edge of the vbx device implanted on (b)(6) 2021.On (b)(6) 2023, a balloon angioplasty with implant of a peripheral stent was performed.The patient tolerated the procedure.
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 b14: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: device remains implanted.Therefore, direct product analysis was not possible.Images were not provided.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, 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
Clinical study notification was received: on (b)(6) 2021, a study patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprostheses (tambe) and gore® viabahn® vbx balloon expandable endoprostheses (vbx devices) were implanted in the visceral arteries as branch devices.On (b)(6) 2021, an additional vbx device was implanted in the left renal artery as a second distal extension in a post-treatment procedure.On (b)(6) 2023, it was observed the patient had developed a stenosis at one end of the left renal vbx device.As reported, this was attributed to the vbx device implanted on (b)(6) 2021.On (b)(6) 2024, the vbx device stenosis required balloon angioplasty with implantation of a new vbx device.
Additional Manufacturer Narrative
B3: date of event was updated.B5: event description was updated ((b)(6) 2024) with information received recently.

• 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: 18030807
• Report Number: 2017233-2023-04367
• Device Sequence Number: 12474979
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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 Expiration Date: 01/12/2024
• Device Catalogue Number: BXA067902A
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 65 KG