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	TGM343415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Insufficient Information (4580)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgmr404015/(b)(4) udi (b)(4).
Event or Problem Description
The following was reported: on (b)(6) 2021, the field sales associate (fsa) was supporting a case to reintervene on a pseudoaneurysm of the proximal anastomosis site of a 24mm infrarenal aortobifemoral surgical graft.The patient is believed to have initially presented in 2017 or 2018 with a type a dissection with extension into the iliac arteries, and had the following procedures prior to the planned reintervention of the proximal anastomosis site: aortic valve and ascending surgical replacement.Redo sternotomy for surgical arch replacement with a 32mm dacron elephant trunk.Placement of a conformable gore¿ tag¿ thoracic endoprosthesis (tgu404020/(b)(4)) in the elephant trunk (performed on (b)(6) 2018).Infrarenal aortobifemoral surgical graft.On (b)(6) 2020, two other conformable gore¿ tag¿ thoracic endoprostheses (tgm343415/(b)(4) and tgmr404015/(b)(4)) were put in distal to the tgu404020 device.It is unknown what the physician was treating at that time.On (b)(6) 2021, there was a reintervention, a conformable gore¿ tag¿ thoracic endoprosthesis (tgm313120) was placed across the proximal anastomosis site of the infrarenal graft.The conformable gore¿ tag¿ thoracic endoprosthesis (tgm313120) was extended proximally with a conformable gore¿ tag¿ thoracic endoprosthesis (tgm343415 and a tgm404020).A conformable gore¿ tag¿ thoracic endoprosthesis (tgm343410) was placed distal to the first tgm313120 for extended coverage.Following placement of the conformable gore¿ tag¿ thoracic endoprostheses, no endoleaks were observed, the arch and visceral bypasses were all patent, and there was no observed flow in the false lumen.The patient tolerated the procedure.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12409327
• Report Number: 2017233-2021-02323
• Device Sequence Number: 4377947
• Product Code: MIH
• UDI-Device Identifier: 00733132646968
• UDI-Public: 00733132646968
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 08/05/2022
• Device Model Number: TGM343415
• Device Catalogue Number: TGM343415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male