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

Catalog Number	VBJR081502A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, age, weight, date of birth, comorbidities, medications.A1: no patient specific details have been provided.Therefore, the patient identifier (in confidence) reflect the gore internal case number.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
On (b)(6) 2026, a male patient underwent an endovascular stenting procedure to treat aneurysm and occlusion of the popliteal artery during which a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was used.During the procedure, the device experienced difficulty during deployment.The deployment line was difficult to pull, and bowstringing was observed.Deployment was stopped.No distal expansion was initiated, and the device was withdrawn back through the sheath.The reporter stated that the guidewire (unknown brand) did not provide sufficient support (not stiff enough), and the up-and-over approach from groin access created a long device path, which could have contributed to the deployment failure.The procedure was completed using another viabahn device.No additional procedural or clinical details were provided, and no patient harm was reported.
Additional Manufacturer Narrative
Updated: h6 adverse event problem codes to account for investigation and findings.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: the device as returned was consistent with attempted deployment and no endo expansion.The deployment knob was detached from the hub with loose deployment line at the knob and transition.The engineers were able to continue deployment via the knob, though replication of the reported failure modes is not always possible because of differences between conditions seen in vivo (i.E., patient anatomy, procedural conditions) and those seen in the laboratory.The root cause of the excessive deployment force was determined to be procedure related.It was reported that ¿¿the guidewire (unknown brand) did not provide sufficient support (not stiff enough), and the up and over approach from groin access created a long device path, which could have contributed to the deployment failure.¿ no information was available to evaluate the stiffness of the guidewire used.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24292348
• Report Number: 2017233-2026-07132
• Device Sequence Number: 21184202
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: (01)00733132623839(17)280523
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 03/03/2026

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: VBJR081502A
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2025
• 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 Sex: Male