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

Model Number	TAC084015A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular treatment of a zone 2 thoracic aortic dissection using gore® tag® thoracic branch endoprostheses (tbe).It was reported that there were no issues observed upon close of the procedure.The proximal landing zone of the tbe device was reportedly free from dissection.On or around (b)(6) 2022, the patient presented to the facility complaining of chest pain.It was reportedly determined that the bare stent row of the proximal end of the tbe aortic component had torn into the patient's aorta.Reportedly the dissection now extended into the patient's ascending aorta creating a retrograde type a dissection.It was reported that, on (b)(6) 2022, the patient underwent reintervention.The physician attempted to place a tbe aortic extender component proximally.However, there was reportedly no room for the device and the physician instead performed a total arch repair with a dacron graft via median sternotomy.The distal end of the dacron graft was sewn into the tbe aortic component on the tbe device's proximal end.There were no further reported issues.The patient tolerated the reintervention.
Additional Manufacturer Narrative
(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 gore® tag® thoracic branch endoprosthesis include, but are not limited to, dissection, perforation, or rupture of the aortic vessel and/or surrounding vasculature, and surgical conversion.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 november 11, 2022, following case review, the physician reported that the dissection is not being attributed to the tbe device.Reportedly, the patient stopped compliance with blood pressure medications post procedure.During follow-up the patient's blood pressure was noted to be high and the pressure was suspected to have caused/contributed to erosion in the ascending aorta and subsequent dissection.Therefore, the dissection is being attributed to non-compliance with medication.
Additional Manufacturer Narrative
H.6.Investigation conclusions codes d1501 and d12 remain unchanged.H.6.Investigation conclusions code d1001 added.
Additional Manufacturer Narrative
H.6.Investigation conclusions codes d12 and d1001 remain unchanged h.6.Investigation conclusions code d1501 updated to code d15.
Additional Manufacturer Narrative
H.6.Investigation conclusions codes d12 and d1001 remain unchanged h.6.Investigation conclusion d15 removed.

• 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: 15740388
• Report Number: 2017233-2022-03450
• Device Sequence Number: 19550291
• Product Code: MIH
• UDI-Device Identifier: 00733132654130
• UDI-Public: 00733132654130
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup,Followup
• Report Date (Section B): 02/02/2023

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: 06/26/2024
• Device Model Number: TAC084015A
• Device Catalogue Number: TAC084015A
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 11/11/2022; 12/12/2022; 02/02/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/08/2022; 12/12/2022; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female