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

Catalog Number	BXA113902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
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.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
The following was reported to gore: on (b)(6) 2025, a patient underwent a reintervention procedure to treat a type 1b endoleak of a previously implanted medtronic stent graft using a gore® excluder® iliac branch endoprosthesis (ibe) iliac branch component, and gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices in the left internal iliac artery.It was reported, an 11 mm x 39 mm vbx device was advanced without resistance to the internal iliac artery.During deployment, for an unknown reason, it appeared that the delivery system balloon was not inflating as expected (even at maximum atm), and the endoprosthesis only partially expanded.The delivery balloon was deflated and reinflated, which successfully expanded the endoprosthesis to the desired diameter.Reportedly, during withdrawal of the delivery catheter, minimal resistance was noticed, however the delivery catheter snapped while inside the patient.The broken catheter was on the guidewire inside the introducer sheath.The decision was made to withdraw the entire system in tandem from the patient.The broken catheter (with the balloon still attached) was removed successfully.Reportedly, up and over access could not be maintained, and therefore unable to balloon the ibe gate.It was reported; the decision was made to end the case and evaluate for endoleaks in 30 days.
Additional Manufacturer Narrative
B20: endoprosthesis remains implanted in patient.Broken delivery catheter was not returned from the facility.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The reported complaint could not be independently confirmed because no product nor images enabling direct assessment of product performance were returned for evaluation.Therefore, an independent assessment of product performance could not be conducted.Therefore, the cause for the reported complaint could not be established with the available information.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21972328
• Report Number: 2017233-2025-06144
• Device Sequence Number: 15493977
• Product Code: PRL
• UDI-Device Identifier: 00733132637720
• UDI-Public: (01)00733132637720(17)271217
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 05/23/2025

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 Catalogue Number: BXA113902A
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male