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

Model Number	TGU373720
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code (b)(4).According to the gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with use of the gore® tag® thoracic endoprosthesis may include but are not limited to pseudoaneurysm.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 was reported to gore: on (b)(6) 2016, the patient underwent an unknown procedure utilizing a conformable gore® tag®thoracic endoprosthesis.On (b)(6) 2022, during a follow up, the physician discovered a pseudoaneurysm at the proximal end of the bare stent on the lateral side of the ctag device.The physician believes the pseudoaneurysm may be related to the bare stent.Reportedly, the physician plans to do a reintervention.Imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following there appears to be a pseudoaneurysm at the level of the bare metal stent portion of the conformable gore® tag® thoracic endoprosthesis.The pseudoaneurysm is ~11mm in length.The pseudoaneurysm is at the location where the bare metal stent rows one and a portion of row two come together.
Additional Manufacturer Narrative
According to the gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with use of the gore® tag® thoracic endoprosthesis may include but are not limited to pseudoaneurysm.
Event or Problem Description
Additional information provided that a reintervention was done on the following: on (b)(6) 2022, the physician did a planned reintervention on endovascular zone 3-lsa pseudoaneurysm at point of bare metal strut utilizing a gore® tag® conformable thoracic stent graft with active control system.The pseudoaneurysm was resolved and the patient tolerated the procedure.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16018181
• Report Number: 2017233-2022-03591
• Device Sequence Number: 20502769
• Product Code: MIH
• UDI-Device Identifier: 00733132618194
• UDI-Public: 00733132618194
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 03/16/2019
• Device Model Number: TGU373720
• Device Catalogue Number: TGU373720
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male