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	TGMR404020
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and / or require intervention include access, delivery and deployment events (e.G.Deployment difficulties/failures).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 27-jun-2024, the patient was treated for a zone 2 thoracic aortic dissection.The physician implanted a gore® tag® thoracic branch endoprosthesis aortic component tac123715a and a gore® tag® thoracic branch endoprosthesis side branch component tsb121506a.The physician then attempted to implant a gore® tag® conformable thoracic stent graft with active control system tgmr404020.Using the gray primary deployment handle, the physician deployed the device to its intermediate diameter.The physician then used the secondary deployment handle to fully open the device, but only about 50% of the device opened to the full diameter.The physician used a gore® molding & occlusion balloon catheter to complete deployment of the device.The device opened quickly and easily using the balloon, and was fully deployed.The patient tolerated the procedure.The physician has no opinion on the cause of the deployment issue.The delivery system was discarded at the facility.The physician was unaware of any malfunction or break in the deployment line.
Additional Manufacturer Narrative
The device evaluation determined the following: no device evaluation could be performed as the device was not returned.The report of partial secondary deployment could not be confirmed with the available information.No root cause for the reported inability to deploy to full diameter could be identified.A review of the manufacturing records indicated that the manufacturing lot met all pre-release specifications and at the time of manufacturing, there were no capas or ncrs related to this event.No images could be provided for an imaging evaluation.Based on the event description and this investigation, no manufacturing deficiencies could be confirmed, so no capa request is required.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19816479
• Report Number: 2017233-2024-05141
• Device Sequence Number: 8665439
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/19/2024

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
• Device Catalogue Number: TGMR404020
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 153 KG