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

Catalog Number	VBJR070502A
Medical Device Problem Codes	Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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.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 an endovascular procedure for an unknown etiology in an unspecified anatomical location utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).Reportedly, during the procedure, the delivery system catheter advanced through an unknown size / brand introducer sheath over an unspecified size /brand guidewire to the target treatment site.During deployment, it was reported the endoprosthesis would not deploy.It was reported there was no patient harm to the patient.
Event or Problem Description
On (b)(6) 2025, a patient underwent an endovascular procedure for peripheral artery disease (pad) in the left lower extremity, including iliac and femoral arteries, utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).The procedure included angiogram, arteriogram, venogram, percutaneous intervention with any combination of angioplasty, atherectomy, thrombolysis, thrombectomy, and stent placement.During the procedure, the delivery system catheter advanced through an unknown size/brand introducer sheath over an unspecified size/brand guidewire to the target treatment site.During deployment, the endoprosthesis would not deploy.The deployment line was pulled at a normal pace but broke.It was reported there was no distal expansion initiated from the attempted deployment the delivery catheter was withdrawn over the guidewire.The undeployed endoprosthesis had shifted down slightly on the delivery catheter, but everything else was in normal condition.It was reported there was no patient harm.
Additional Manufacturer Narrative
B3 / b4 / b5 / b6.Updated describe event or problem - new information received.H6 adverse event problem codes.Added medical device problem code - a0401 (break) - new information.Updated codes based on investigation findings.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The reported complaints of deployment line breakage during attempted deployment and displacement of the endoprosthesis during withdrawal could not be independently confirmed because there were no items returned for evaluation.The reported endoprosthesis displacement is consistent with withdrawal through the sheath as reported.The cause for the reported deployment line breakage during attempted deployment could not be established with the available information.

• 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: 23856705
• Report Number: 2017233-2025-06985
• Device Sequence Number: 13297935
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: (01)00733132623761(17)280930
• 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): 01/15/2026

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: VBJR070502A
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male