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

Catalog Number	BXBL087902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device met pre-release manufacturing specifications.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.It was reported that the vbx device endoprosthesis became dislodged when it was attempted to be withdrawn back into the introducer sheath.The vbx device instructions for use warn against withdrawal of the endoprosthesis back into the introducer sheath after it has been fully introduced due to the potential for endoprosthesis dislodgement among other potential complications.The root cause of the reported dislodgement is consistent with the potential use error of attempted withdrawal of the vbx device endoprosthesis back into the sheath after it has been fully introduced.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 information was reported to gore: the patient underwent endovascular treatment of occlusion with gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) in the right and left iliac arteries during a kissing stent procedure.Reportedly, during the advancement of the 8mm x 79mm vbx device into the right iliac, the technician lost wire access and the physician attempted to remove the vbx device back through the 8frx11cm cordis bright tip introducer sheath and the device became dislodged.The physician advanced a mustang balloon through the vbx device and deployed it in the right common iliac artery just below the hypogastric artery.The physician then advanced a new vbx device and got it into position in the right iliac and advanced a 8mm x 29mm into the left iliac, in the kissing stent configuration.He then made the decision that he wanted an 8mm x 39mm vbx device and attempted to remove the vbx device through the 8frx11cm cordis bright tip introducer sheath, and the second device became dislodged.The physician advanced a mustang balloon through the vbx device and deployed it in the common left iliac artery just below the hypogastric artery.The procedure was successfully completed with a new vbx device.

• Brand Name: REDUCED PROFILE GORE® VIABAHN® VBX 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24875860
• Report Number: 2017233-2026-07371
• Device Sequence Number: 18373094
• Product Code: PRL
• UDI-Device Identifier: 00733132658534
• UDI-Public: (01)00733132658534(17)280330
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/14/2026

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: BXBL087902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: 75 YR
• Patient Sex: Male