MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGT3115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore.On unknown date, total arch replacement was performed using a surgical graft.On (b)(6) 2011, the patient underwent treatment of thoracic aortic aneurysm using two gore® tag® thoracic endoprostheses (proximal-tgt3115/9042283, distal-tgt3420/9077511).The proximal end of the tgt3115 was placed in the distal anastomosis of the surgical graft.The procedure was finished with no evidence of endoleak.The patient tolerated the procedure.On unknown date, it was confirmed that the tgt3115 migrated distally.There was an unknown leak between the distal anastomosis and the tgt3115.An intravascular ultrasound (ivus) was performed in order to determine the origin of the leak, but it was unable to determine the exact origin of the leak.The physician reportedly stated that the exact cause of the leak was unknown.The flare (the proximal end) of the tgt3115 might have caused a damage to the surgical graft and it resulted in a leak from the surgical graft.On (b)(6) 2018, the patient underwent secondary intervention for treatment of unknown leak.A conformable gore tag® thoracic endoprosthesis (tgu343420j) was implanted covering the distal anastomosis of the surgical graft and the proximal end of the tgt3115.Post-ballooning was performed.The unknown leak was resolved and the patient tolerated the procedure.(this reintervention information which was performed on (b)(6) 2018 was captured in psts#: 38243) following information is captured in this case: (b)(6).On an unknown date, the descending aortic aneurysm became enlarged (amount unknown).On (b)(6) 2023, reintervention was performed.Nbca was injected into the aneurysm.Then, first gore® tag® conformable thoracic stent graft with active control system (ctagac) was implanted distally and second gore® tag® conformable thoracic stent graft with active control system was implanted to reline the junction between the first gore® tag® conformable thoracic stent graft with active control system and previous implanted endoprostheses.The fsa provided additional information on may 18, 2023: the obvious cause of the aneurysm enlargement was unknown but it is high possibility the aneurysm enlargement was due to a type ii endoleak.
Additional Manufacturer Narrative
H3: code ¿other¿ was selected as no device was returned.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.
Additional Manufacturer Narrative
Emdr section h6 codes b, c, d updated to reflect results of investigation.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17105076
• Report Number: 2017233-2023-03999
• Device Sequence Number: 2773413
• Product Code: MIH
• UDI-Device Identifier: 00733132613625
• UDI-Public: 00733132613625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 03/31/2014
• Device Model Number: TGT3115
• Device Catalogue Number: TGT3115
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2011
• 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
• Patient Age: 80 YR
• Patient Sex: Male