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	TGM343410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/05/2023
Type of Reportable Event	Death
Event or Problem Description
The following information was reported to gore through the (b)(6) pivotal clinical study.On (b)(6) 2022, the patient underwent endovascular treatment of a thoracic dissection, zone 0/1 using gore® tag® thoracic branch endoprostheses and gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2022, the patient admitted to the hospital with pleural effusion.He developed a urinary tract infection and it was resolved on (b)(6).On (b)(6) 2022, the patient was diagnosed sepsis based on blood culture test.On (b)(6) 2023, the patient had hemoptysis and suspected a descending aortic rupture.On (b)(6) 2023, ct angiography confirmed the descending thoracic aortic rupture.The rupture site was around the distal landing zone.No treatment was performed at this moment and the event on going.Reportedly the event is unrelated to devices and procedure.The physician's comment: this event may be related to the vascular impact of an infection (sepsis due to urinary tract infection, covid-19).The patient is monitored, and will be discussed about the treatment plan.The possible reintervention plan includes an additional tevar for the distal aorta.
Additional Manufacturer Narrative
Code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.\code b20-device remains implanted.Device remains implanted and no reintervention surgery is planned at this time.As additional physical investigation could not be performed on the device, a definitive root cause could not be determined for the reported issue.It should be noted that, per the gore® tag® conformable thoracic stent graft with active control instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, aortic rupture and rupture of the aortic vessel and surrounding vasculature.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.
Event or Problem Description
On (b)(6) 2023, the patient expired.The patient had hemoptysis and it was suspected an aortic rupture.Reviewing ct images, the cause of death was determined as aggravated rupture of the descending aorta, which had already been reported.It was reported that the ruptured site had been thrombosed but new blood flow at the site have caused bleeding.Device infection could not be determined.Physician also reported the following: it cannot be ruled out that the sepsis that developed from a urinary tract infection might have occurred due to the device infection.However, there is no direct relation between the event and the device or the procedure.The initial rupture had successfully formed thrombosis.However, because of the infection spreading in thrombosis within the false lumen, new blood flow at the site have developed bleeding and re-rupture.¿.
Additional Manufacturer Narrative
Updated b5 with additional information.H6 code f02-used to capture patient death.Conclusion code remains unchanged.
Event or Problem Description
On (b)(6) 2022, as a treatment for a descending aortic rupture, left thoracic cavity drainage was performed.Fluid/blood/oxygen therapy and suction of bloody sputum were also performed for the treatment of the descending aortic rupture.
Additional Manufacturer Narrative
Section h, code f12 was added to capture treatment of descending thoracic aortic rupture-left thoracic cavity drainage were performed.Fluid/blood/oxygen therapy and suction of bloody sputum were also performed.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16452110
• Report Number: 2017233-2023-03757
• Device Sequence Number: 5859880
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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: 03/28/2024
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 11/08/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/14/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: Other; Death
• Patient Age: 87 YR
• Patient Sex: Male