MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	VBJR060202A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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), the patient underwent an unknown etiology where a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was intended to be implanted in the distal iliac artery.Using a cook 6 fr introducer sheath and a boston scientific v-18¿ controlwire¿ guidewire, the physician reach the target treatment area.Deployment was initiated by pulling on the deployment line, however, the viabahn device was unable to deploy as the physician was only able to pull less than three inches of the deployment line before meeting resistance.The viabahn device was withdrawn through the sheath and the procedure was completed using a gore® viabahn® vbx balloon expandable endoprosthesis device.The viabahn device was set aside for return.The physician suspects the deployment line wasn't pulled hard enough.There was no reported harm to the patient.
Additional Manufacturer Narrative
C1: added name and manufacturer.H6: removed code d16 and c21 along with adding d15.Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The delivery system was returned to gore for evaluation.Evaluation of the returned product indicates the viabahn device as returned was not consistent with the report of a stuck deployment line during attempted deployment.During the engineering evaluation, deployment could be continued by pulling the knob.The root cause of the partial deployment with stuck deployment line could not be established with the available information, including device evaluation.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23415277
• Report Number: 2017233-2025-06756
• Device Sequence Number: 15689826
• Product Code: NIP
• UDI-Device Identifier: 00733132623945
• UDI-Public: (01)00733132623945(17)270814
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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
• Report Date (Section B): 12/03/2025

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: VBJR060202A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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 Sex: Female