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

Catalog Number	BXB063902A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent treatment for a splenic artery aneurysm.Access was from the artery via the radial approach from the wrist.A 6fr terumo radial sheath was used to advance a reduced profile gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) over a supra core guidewire.It was reported that during the procedure, physician encountered difficulty deploying a 6mm x 39mm vbx device/stent due to the patient's tortuous anatomy.The physician-maintained pressure at the nominal level for about 20 seconds before slowly deflating the balloon.When pushed forward, the balloon separated from the vbx device/stent.The catheter was then pulled back with some force, causing the sheath to advance forward.Initially, imaging appeared normal; however, a second image from a different angle revealed bleeding between the vbx device/stent and the sheath, suggesting a possible perforation.The physician suspected the bleeding may have been caused by the forceful retraction of the delivery catheter due to patient's tortuous anatomy.Reportedly, the stiction had already been resolved prior to the perforation.After the delivery catheter with balloon were removed, two additional 6mm x 29mm vbx devices were implanted to cover the perforation.The procedure concluded with a good outcome.
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 b20: device remains implanted, and no images were provided; therefore, direct product analysis was not possible.H6 - code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: 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.As reported, the physician encountered difficulty deploying the device due to the patient¿s tortuous anatomy; therefore, the cause for this reported failure mode can be attributed to the patient condition.There was reported difficulty with the balloon separating from the fully deployed stent, however it separated after pushing the catheter forward; the cause for this reported failure mode could not be established with the available information.During attempted withdrawal, it was reported that the physician retracted the catheter with excessive force due to the patient¿s tortuous anatomy, which was thought to have caused a possible vessel perforation; therefore, the cause for this reported failure mode can also be attributed to the patient condition.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: 21613116
• Report Number: 2017233-2025-05941
• Device Sequence Number: 18030848
• Product Code: PRL
• UDI-Device Identifier: 00733132658442
• UDI-Public: (01)00733132658442(17)270721
• 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
• 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): 03/14/2025

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: BXB063902A
• 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: 02/07/2025
• Initial Report FDA Received Date: 03/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2024
• 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
• Patient Age: 32 YR
• Patient Sex: Female