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

Model Number	TAC124020A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	09/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent emergency treatment of a symptomatic zone 0 dissecting aneurysm using gore® tag® thoracic branch endoprostheses (tbe) and gore® tag® conformable thoracic stent grafts with active control system.A gore® dryseal flex introducer sheath and a gore® tri-lobe balloon catheter were used as accessories in the procedure.The patient's anatomy was reported to be extensively tortuous.On (b)(6) 2022, the gore representative was made aware that the patient had spinal cord ischemia which was observed on the evening of the index procedure.It was reported that a non-prophylactic spinal drain was placed post-procedure and a plan was made to discharge the patient to a rehab center.The spinal cord ischemia is ongoing.On (b)(6) 2022, it was reported that the patient's symptoms are improving.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tsb121506a/ serial #(b)(4), udi #(b)(4) as the same system of components.Catalog #tgmr373720/ serial #(b)(4), udi #(b)(4).Catalog #ttgmr313120/ serial #(b)(4), udi #(b)(4).Catalog #bcl2645/ serial #(b)(4), udi #(b)(4).Catalog #dsf2665/ serial #(b)(4), udi #(b)(4).(b)(4).According to the gore® tag® thoracic branch endoprosthesis instructions for use, potential adverse events and complications that may occur with the use of the gore® tag® thoracic branch endoprosthesis include, but are not limited to, embolism (micro and macro) with transient or permanent ischemia, peripheral malperfusion or ischemia, and neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).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.
Additional Manufacturer Narrative
H.6.Investigation conclusions code d15 and d12 remain unchanged.Upon review of the event by the product specialist it was determined that the tsb121506a (serial #(b)(6)) gore® tag® thoracic branch endoprosthesis - side branch did not cause or contribute to the spinal cord ischemia event.As there are no allegations of deficiency against the side branch device, this device will not be included in the report or investigation.

• Brand Name: GORE® TAG® THORACIC BRANCH 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15592755
• Report Number: 2017233-2022-03398
• Device Sequence Number: 16723222
• Product Code: MIH
• UDI-Device Identifier: 00733132654246
• UDI-Public: 00733132654246
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 07/18/2024
• Device Model Number: TAC124020A
• Device Catalogue Number: TAC124020A
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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
• Patient Sex: Male