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

Model Number	TGT3415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted the gore® tag® thoracic endoprosthesis instructions for use state ¿complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, aneurysm enlargement 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.
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® thoracic endoprosthesis.On an unknown date, a follow-up examination reportedly revealed aneurysm enlargement (amount unknown).No endoleak was observed during the examination.It was reported the patient also developed occasional hemoptysis.On (b)(6) 2022, a reintervention was performed.An intra-operative angiograph showed no endoleak.Two gore® tag® conformable thoracic stent grafts with active control system (ctag-ac) were implanted as proximal and distal extension of the existing gore® tag® thoracic endoprosthesis.After touch-up ballooning was performed, an angiograph reportedly revealed the proximal ctag-ac moved distally about 2cm upon deployment.The cause of the alleged device movement is unknown, and no issues were reported with handling and operating the device per the instructions for use.According to the report, the proximal ctag-ac was positioned at nearly same level as the proximal end of the existing gore® tag® thoracic endoprosthesis.No additional treatment was performed, and the physician will continue to monitor the patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: conclusion coding updated.It should be noted the gore® tag® thoracic endoprosthesis instructions for use state ¿complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, aneurysm enlargement and reoperation.¿.

• Brand Name: 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15265719
• Report Number: 2017233-2022-03249
• Device Sequence Number: 5731952
• Product Code: MIH
• UDI-Device Identifier: 00733132613649
• UDI-Public: 00733132613649
• 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: 2011
• 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): 09/09/2022

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: 05/31/2014
• Device Model Number: TGT3415
• Device Catalogue Number: TGT3415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2011
• 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: 84 YR
• Patient Sex: Male