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	TGMR404010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, the patient underwent an unknown procedure utilizing a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2022, during a follow-up ct scan, a type 1a endoleak was discovered going into the diverticulum of the aberrant right subclavian artery.On (b)(6) 2023, the patient underwent an endovascular reintervention in zone 2- lcc arch utilizing a gore® tag® thoracic branch endoprosthesis.Reportedly, during the procedure, there was a deployment inaccuracy of the aortic component with the tbe device.The initial deployment of the device occluded the innominate artery; however, the physician was able to pull the device back to allow flow into the innominate artery.The implant was successful, and the patient tolerated the procedure.Imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: post-implant cta submitted for evaluation, arterial phase only.Re-intervention images not available.Patient has a bovine arch.Length from the lsa to the proximal end of the device measures ~ 8.5 mm on centerline, ~ 12.5 mm on the outer curve.There is a lack of wall apposition at the proximal end of the circumferential device.There is a contrast-like density outside of the proximal end of the device, contrast cannot be confirmed without a non-contrast phase to compare with the submitted arterial phase cta.If contrast could be confirmed, this would be consistent with the reported type 1a endoleak.
Additional Manufacturer Narrative
Code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.It should be noted the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) state ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to endoleak and reoperation.¿ 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16372605
• Report Number: 2017233-2023-03721
• Device Sequence Number: 6813882
• Product Code: MIH
• UDI-Device Identifier: 00733132646838
• UDI-Public: 00733132646838
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: 01/12/2024
• Device Model Number: TGMR404010
• Device Catalogue Number: TGMR404010
• 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: 01/11/2023
• Initial Report FDA Received Date: 02/14/2023
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male