MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGMR373710
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, this patient underwent open repair for a dissection with a gore® tag® conformable thoracic stent graft with active control system.It was reported that the device was loaded on to a meier¿ guidewire and advanced up the patient¿s open chest up to the descending thoracic aorta to the level of the left subclavian artery and deployed to full diameter.It was reported that the physician went to remove the rest of the delivery system the line to pull the angulation wire had popped off.The red lock wire handle was rotated and when pulled back it failed to remove the angulation fibers.The physician reported he was unable to get the device to release off the catheter, so they just slid it right back out.The device was discarded at the site.There was no blood loss or harm to the patient reported.The procedure was concluded with no gore devices implanted.The patient is reported to be doing well and has already been discharged to home.As this procedure was off label and not supported by gore, the field sales associate for the account contacted the physician to confirm if the back-up hatch mechanism had been utilized; and was told it had not been.
Additional Manufacturer Narrative
The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the stent graft was returned attached to the catheter and deployed to full diameter.The primary and secondary deployment lines and handles were not returned with the device.The lockwire was returned separated from the lockwire handle.The lockwire was returned properly routed through the catheter transition, skives, stent graft, and into the curved olive.One end of the lockwire was broken as returned and was visible through the access hatch.The other broken end of the lockwire with the ferrule attached was present within the white handle component.The device evaluation showed damage on the broken end of the lockwire which may indicate the lockwire was cut in the backup access hatch.The lockwire connector and lockwire handle were not returned.The angulation fibers remained routed through the stent graft and catheter.The angulation fibers were not visible in the access hatch and the angulation handle was not returned.During testing for design validation and verification, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.Based on the evaluation, the reported difficulty and inability to remove the lockwire could not be confirmed.There is potential that off-label use in an antegrade hybrid fashion may have contributed to the reported event.Based on the event description and device evaluation, no manufacturing deficiencies could be confirmed so no capa request is required.Events will continue to be monitored by gore,.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21181924
• Report Number: 2017233-2025-05745
• Device Sequence Number: 4287040
• Product Code: MIH
• UDI-Device Identifier: 00733132646807
• UDI-Public: 00733132646807
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/24/2025

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: TGMR373710
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Unknown