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

Catalog Number	VBHR101002A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, gender, 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) 2025, the patient underwent treatment for an external iliac pseudoaneurysm from a prior procedure using a gore® viabahn® endoprosthesis with heparin bioactive surface.It was reported that the physician accessed the treatment via a contralateral approach using either an 8f terumo sheath (25cm) or cordis brite tip sheath introducer (23 cm), over an.035" terumo stiff glidewire.Reportedly, there was initial difficulty crossing the target treatment area, which had previously been treated¿possibly with an endarterectomy.At the target site, the endoprosthesis was deployed in the intended location.Upon withdrawal of the delivery system, it was reported the delivery catheter folded in half and broke in half.A penumbra lightning catheter was used to aspirate and retrieve the separated portion back into the sheath.Both the catheter and sheath were removed successfully, and the endoprosthesis remained in place.The physician was uncertain about the cause of the delivery system separation and reportedly did not observe any kinking of the catheter.It was reported there was no reported impact to the patient.
Additional Manufacturer Narrative
Updated h6 investigation codes: the manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Product return evaluation: the reported broken components, were confirmed by the engineering evaluation.The distal shaft with bonded distal tip was observed separated from the dual lumen and transition.Additionally, the transition was found almost completely separated from the dual lumen.There is evidence the catheter assembly went through the bonding process as the <90° visibly raised collar edge on the catheter circumference is consistent with normal manufacturing.There was no report of excessive force used during withdrawal.Therefore, the root cause of the broken components cannot be established within the engineering evaluation.

• 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: 23452285
• Report Number: 2017233-2025-06768
• Device Sequence Number: 15705290
• Product Code: NIP
• UDI-Device Identifier: 00733132646043
• UDI-Public: (01)00733132646043(17)280508
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/21/2025

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: VBHR101002A
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2025
• 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: Unknown