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

Catalog Number	VBJR050502A
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the patient underwent a transcarotid artery revascularization (tcar) procedure to treat a carotid artery aneurysm, during which a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was intended to be implanted.The physician performed a cut down in the carotid with the silk road system.The viabahn device reached the target treatment area going through an 8fr introducer sheath (unspecified manufacture) and, over 0.018" guidewire.The physician began a slow deployment of the viabahn device with the intent of anchoring the distal portion in the internal carotid artery.However, due to the interaction between the guidewire and the slow deployment within the aneurysmal segment, the device did not deploy properly.Approximately four-fifths of the viabahn endoprosthesis deployed.The physician attempted to force completion by pulling more firmly on the deployment line.This action resulted in the deployment line breaking.To retrieve the viabahn device, the physician extended the carotid arteriotomy and advanced the partially deployed device, with the olive tip, into the 8 fr sheath, allowing both the viabahn device and the sheath to be withdrawn in tandem from the patient.The physician then restarted the procedure using all new components: silk road system, 8 fr introducer sheath, and 0.018" guidewire.The procedure was successfully completed by implanting 5 × 5 cm and 7 × 5 cm viabahn devices.The patient had a favorable outcome.The physician believes the issue was related to the guidewire interaction and the deployment technique.
Additional Manufacturer Narrative
H6: code c21 product evaluation is under investigation.Results will be included in the final report.C19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.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.

• 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: 24732448
• Report Number: 2017233-2026-07305
• Device Sequence Number: 13367567
• Product Code: NIP
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 05/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VBJR050502A
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2024
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male