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	TGM454510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #rlt351414/ serial #(b)(4)/ udi #(b)(4) which has been captured on manufacturer report #3007284313-2022-02095.Catalog #plc141400/ serial #(b)(4)/ udi #(b)(4).Catalog #plc121400/ serial #(b)(4)/ udi #(b)(4).Catalog #tgm454510/ serial #(b)(4)/ udi #(b)(4).Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.(b)(4).According to the gore® tag® conformable thoracic stent graft with active control system ifu, the gore® tag® conformable thoracic stent graft is intended for endovascular repair of all lesions of the descending thoracic aorta and potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, infection (e.G., aneurysm, device or access sites).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak, and infection (e.G., aneurysm, device, or access sites).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 an abdominal aortic aneurysm at mount sanai hospital using gore® excluder® aaa endoprostheses and two gore® tag® conformable thoracic stent grafts with active control system in an off label manner in the patient's abdominal aorta.On or around (b)(6) 2022, the patient presented to north shore university hospital.A proximal type i endoleak was observed with enlargement of the aortic neck.Aneurysm enlargement was not reported.It was also reported that there was a high suspicion of graft infection as the tissue surrounding the graft was inflamed.There was no reported preexisting infection, and the physician suspected that the graft may have caused/contributed to the infection as the index procedure was recent.The physician suggested that the devices should be explanted.However, there is no planned date of explant as the patient may return to mount sanai hospital for the explant procedure.
Additional Manufacturer Narrative
H.6.Investigation findings: code c19 - review of the manufacturing and sterilization paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d15 - confirmation of graft infection and/or potential cause could not be determined with the available information.H.6.Investigation conclusions code d12 added.According to the gore® tag® conformable thoracic stent graft with active control system ifu, the gore® tag® conformable thoracic stent graft is intended for endovascular repair of all lesions of the descending thoracic aorta and potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, infection (e.G., aneurysm, device or access sites).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak, and infection (e.G., aneurysm, device, or access sites).H.6.Investigation findings: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15332384
• Report Number: 2017233-2022-03283
• Device Sequence Number: 15072528
• Product Code: MIH
• UDI-Device Identifier: 00733132646982
• UDI-Public: 00733132646982
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/30/2022

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: 09/18/2024
• Device Model Number: TGM454510
• Device Catalogue Number: TGM454510
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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; Other
• Patient Age: 75 YR
• Patient Sex: Female