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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2019, the patient underwent endovascular treatment of an unknown etiology.A position modified endograft was placed in the patient's aorta and an icast balloon-expandable covered stent graft was used in the patient's renal artery.A gore® excluder® iliac branch component (ibe) was placed distally in the patient's left common iliac artery and an additional non-gore cuff device was used as a bridging stent.It was noted that multiple gore® viabahn® vbx balloon expandable endoprostheses and a medtronic endurant aortic cuff were also used.The patient's anatomy was reportedly extremely tortuous.On (b)(6) 2022, reintervention was performed to treat two type iii endoleaks.The first endoleak was reported between the non-gore aortic endograft and the icast device in the patient's renal artery.The second type iii endoleak was reported between the ibe device and the non-gore cuff that were placed distally in the patient's left common iliac artery.A proximal type i endoleak was also observed on the non-gore endograft.It was reported that a gore® tag® conformable thoracic stent graft with active control system was advanced in an attempt to treat the proximal type i endoleak.Reportedly, due to the patient's tortuous anatomy, the device was unable to advance proximally, so the physician opted to deploy the device in the patient's left common iliac artery to treat the type iii endoleak on the ibe device.The deployment was successful and the delivery catheter was withdrawn with no reported issues.The type iii endoleaks were successfully treated.Treatment of the proximal type i endoleak was planned for a later date.It was reported that the patient coded on or around (b)(6) 2022.The patient subsequently expired.The cause of death was reportedly unknown, but it was reported that the patient had multiple comorbidities and the physician did not suspect that the patient's death was attributed to the placement of the ctag device.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #ceb231410a/ serial (b)(4)/ udi (b)(4) which is captured on manufacturer report #3013164176-2022-01525.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.Investigation findings: the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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, death.Furthermore, the ifu states that the gore® tag® conformable thoracic stent graft is intended for endovascular repair of all lesions of the descending thoracic aorta.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.

• 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: 15697571
• Report Number: 2017233-2022-03435
• Device Sequence Number: 20533461
• Product Code: MIH
• UDI-Device Identifier: 00733132646807
• UDI-Public: 00733132646807
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 10/30/2022

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: 05/14/2025
• 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: 09/30/2022
• Initial Report FDA Received Date: 10/30/2022
• Date Device Manufactured: 05/16/2022
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Male