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

Catalog Number	BXA115902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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.H6 - code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.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
On (b)(6) 2025, a patient underwent a thoracoabdominal branch endoprosthesis (tambe) procedure to treat an aneurysm.During this procedure, a 11mm x 59mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) and a 9mm x 79mm vbx device were used as branch devices in the visceral arteries.It was reported during the procedure, while advancing the 11mm x 59mm vbx device over an unknown brand guidewire through a tourguide introducer sheath (size unknown), resistance was encountered as the physician attempted to reach the target treatment site (celiac artery).This resistance was caused by stenosis in the celiac artery.As the physician tried to remove the vbx device, it became caught around a bend due to patient's very tortuous anatomy.In addition, the vbx device also got stuck on one of the wires on the tambe port.A snare was used to remove the vbx device after the stent became dislodged from the catheter.A replacement vbx device was used successfully.It is unknown if the vessel was predilated.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Engineering evaluation: the primary reported failure mode of inability to advance the vbx device to the target location could not be independently confirmed with the information available, including evaluation of the returned vbx device.Clinical factors potentially impacting vbx device advancement (e.G.Patient anatomy, procedural conditions) cannot be replicated during evaluation in the laboratory setting.The reported that the vbx device endoprosthesis became dislodged was confirmed.The vbx device as returned exhibited damage (endoprosthesis compressed and separated from delivery system with damage to stent rings) consistent with difficulty encountered during withdrawal of the vbx device and retrieval of the endoprosthesis via snare as reported.According to the information provided, the cause or the difficulty advancing the vbx device to the target location was related to the patient condition (stenosis).And the cause of the reported endoprosthesis dislodgement during withdrawal was also related to the patient conditions (stuck on bend in tortuous anatomy).
Additional Manufacturer Narrative
Corrected data: g4 added 510(k) number h6 added b01 device was returned and evaluated.

• 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: 22057873
• Report Number: 2017233-2025-06198
• Device Sequence Number: 12839263
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: (01)00733132637744(17)270314
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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: BXA115902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/16/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/10/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2024
• 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: Female