MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TRI LUMEN CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	TLC140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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
The following was reported to gore: on (b)(6) 2026, the patient underwent tambe endovascular treatment for an arterial dissection utilizing multiple gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices in the visceral vessels and a gore® tri-lumen catheter (tlc).A gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was intended to be implanted in the left renal artery, however, it was left implanted in the right innominate artery.It was reported the physician reached the left renal artery and pulled the deployment line all the way.However, the physician had difficulty visualizing if the viabahn endoprosthesis expanded properly under fluoroscopic imaging.The delivery catheter was then withdrawn and it wasn¿t until the physician was at the right innominate artery when they noticed the viabahn endoprosthesis did not deploy in the left renal artery.When being withdrawn, the viabahn device met resistance by getting caught on an unspecified material, causing the viabahn endoprosthesis to dislodge into the right innominate artery.The viabahn endoprosthesis did not cover any major branch vessels, and the right innominate artery still had proper blood flow.The viabahn endoprosthesis was left as endo trash and the procedure was completed by placing a new viabahn device in left renal artery.Additionally, it was reported that the tip of the gore® tri-lumen catheter became detached while the catheter was being withdrawn to load an additional 0.018-inch guidewire.The physician did a quick cross over the wire and successfully pulled the catheter out along with the tip.Reportedly, the tlc tip separation was attributed to tortuous challenges related to the patient¿s anatomy.No harm to the patient was reported as a result of these adverse events with remainder of the procedure completed successfully and the patient¿s status at the end of the procedure was reported as stable.(b)(6): -other is used to cover the viabahn endoprosthesis dislodgment in unintended area.

• Brand Name: GORE® TRI LUMEN CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24997950
• Report Number: 3007284313-2026-04740
• Device Sequence Number: 18334068
• Product Code: DQY
• UDI-Device Identifier: 00733132644421
• UDI-Public: (01)00733132644421(17)281012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180919
• 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
• Report Date (Section B): 04/27/2026

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: TLC140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male