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

Model Number	TGMR404015
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Also was involved a tac124515c/ 23373578 udi# (b)(4).The medwatch report was sent to fda separately on december 14, 2022.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to aortic expansion (e.G., aneurysm), endoleak and reoperation.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.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) 2022, the patient underwent endovascular treatment of a thoracic aortic aneurysm with gore® tag® conformable thoracic stent graft with active control system (ctag-ac)-most adjacent to the tbe aortic component.Treatment area was zone 0-proximal to the brachiocephalic trunk, distal to the sinotubular junction.On (b)(6) 2021, the pre-treatment computed tomography (ct) imaging showed that the maximum diameter of the aortic aneurysm was 58mm.It was reported that on (b)(6) 2022, a follow up ct revealed a type ii endoleak from the left subclavian artery.The maximum diameter of the aortic aneurysm was 54mm.The event was ongoing.The physician was monitoring the patient.On (b)(6) 2022, the maximum diameter of the aortic aneurysm was 57mm.On (b)(6) 2022, a persistent type ii endoleak was noted.According to the site, it was related with the endovascular procedure.The patient underwent an embolization procedure.
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular treatment of a zone 0 thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system (ctag-ac)-most adjacent to the gore® tag® thoracic branch endoprosthesis.According to the site, on (b)(6) 2021, the pre-treatment computed tomography (ct) imaging showed that the maximum diameter of the aortic aneurysm was 58mm.It was reported by the site that on (b)(6) 2022, a type ii endoleak from the left subclavian artery was determined.The event was ongoing.The physician was monitoring the patient.The follow up ct scans showed that the maximum diameter of an aortic aneurysm/ lesion increased in size from 54 mm on (b)(6) 2022 to 57mm on (b)(6) 2022 as reported by the core lab.On (b)(6) 2022, a persistent type ii endoleak was noted.According to the site, it was related with the endovascular procedure.The patient underwent an embolization procedure.
Additional Manufacturer Narrative
B5: the dates in the description summary were corrected.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15984016
• Report Number: 2017233-2022-03575
• Device Sequence Number: 17570400
• Product Code: MIH
• UDI-Device Identifier: 00733132646845
• UDI-Public: 00733132646845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2024
• Device Model Number: TGMR404015
• Device Catalogue Number: TGMR404015
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White