MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU313115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medications: not made available.Medical history: stroke (b)(6) 2017, congestive heart failure, hypercholesterolemia, hypertension, valvular heart disease, cardiac arrhythmia, previous aortic surgery in ascending aorta, aortic valve (root and arch replacement), thrombectomy of right proximal mca, prior sternotomy and thromboembolic event.Communication/interviews.Additional information in regard to the event and images of the case were requested.The provided additional information is captured in the event description.Device not accessible for testing: the medical device remains implanted and was therefore not available for return and evaluation.No device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, aortic expansion.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
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2017, the patient underwent endovascular treatment of a thoracic aortic dissection with conformable gore® tag® thoracic endoprostheses (tgu313115/16209151)-most adjacent to the tbe aortic component.On (b)(6) 2022, computed tomography and ultrasound imaging were performed.According to the event report there was an expansion of the "excluded aneurysmal sac" from 52mm to 58mm.On (b)(6) 2022, follow up computed tomography was conducted and showed an unchanged appearance of the excluded aneurysm sac and residual dissection flap.Stable aortic measurements were observed with a maximum diameter of 58 mm at the mid descending thoracic level.As reported the patient was asymptomatic and there are no plans to intervene at this time.The plan is to continue to monitor the patient status.The event is ongoing.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15412254
• Report Number: 2017233-2022-03311
• Device Sequence Number: 20247034
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/13/2022

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: 04/04/2020
• Device Model Number: TGU313115
• Device Catalogue Number: TGU313115
• 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: 08/26/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2017
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG