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	TGM454520
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2011, the patient presented with a mid-descending thoracic aortic aneurysm and underwent treatment utilizing a gore® tag® conformable thoracic stent graft with active control (ctag a/c).The patient tolerated the procedure.On (b)(6) 2017, the patient presented with a type 1a endoleak from the previously placed device and underwent reintervention utilizing a conformable gore® tag® thoracic endoprosthesis (ctag).The tag device was extended to the left subclavian artery.The patient tolerated the procedure.On (b)(6) 2019, the patient presented with a type 1b endoleak and underwent reintervention utilizing a conformable gore® tag®thoracic endoprosthesis (ctag).The patient tolerated the procedure.On (b)(6) 2020, the patient presented with a continued type 1a endoleak and underwent reintervention utilizing a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).The device was placed to partially cover the left subclavian artery due to the continued type 1a endoleak.The patient tolerated the procedure.On (b)(6) 2022.The patient presented with a type 1a endoleak and underwent a carotid-carotid and carotid-subclavian bypass in preparation for future placement of a device to resolve the type 1a endoleak.The patient tolerated the procedure.On (b)(6) 2022, the patient underwent reintervention for resolution of previously observed proximal type 1a endoleak.Reportedly, no type 1b endoleak was observed but the physician extended distally into the celiac artery due to the previously most distal device ending in a bend.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: added component code g04122.Per gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reoperation.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13596468
• Report Number: 2017233-2022-02766
• Device Sequence Number: 17629003
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 04/28/2022
• Device Model Number: TGM454520
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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
• Patient Age: 78 YR
• Patient Sex: Male