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	TGMR373710
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: acetaminophen 325mg, aspirin 81mg, atorvastatin 40mg, vitamin d2, mirtazapine 15mg, nicotine patch, umeclidinium.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, endoleak and reoperation.
Event or Problem Description
On (b)(6) 2021 the patient underwent stage 1 treatment of a thoracoabdominal aortic aneurysm without rupture in the (b)(6) thoracoabdominal branch endoprosthesis (tambe) clinical trial.A conformable (b)(6) endoprosthesis (ctag) was implanted.On (b)(6) 2021 the patient underwent stage 2 treatment with the tambe investigational device.On (b)(6) 2021 a type b aortic dissection was observed and on (b)(6) 2021 the dissection was treated by means of a left carotid subclavian bypass and implantation of a (b)(6) conformable thoracic stent graft with active control system (ctag a/c) proximal to the originally placed ctag device.On (b)(6) 2021 x-ray examination revealed a type ii endoleak originating from the patient's left subclavian artery where the ctag a/c device was located.On (b)(6) 2021 a reintervention was performed whereby embolization of the patient's left subclavian artery proximal to the left vertebral artery origin was performed via left brachial artery access.Embolization was performed using cook medical nester® embolization coils and a medtronic mvp micro vascular plug.It was reported that the completion angiogram demonstrated significant improvement of the type ii endoleak with minimal residual which was reportedly likely due to the residual effect of heparin.The physician's reported impression was that the left subclavian artery was successfully embolized.The type ii endoleak was reportedly resolved.There were no further reported issues.The patient tolerated the reintervention.

• 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: 12912379
• Report Number: 2017233-2021-02574
• Device Sequence Number: 12033324
• Product Code: MIH
• UDI-Device Identifier: 00733132646807
• UDI-Public: 00733132646807
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 01/04/2023
• Device Model Number: TGMR373710
• Device Catalogue Number: TGMR373710
• 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: 11/15/2021
• Initial Report FDA Received Date: 12/01/2021
• Date Device Manufactured: 01/05/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American