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

Catalog Number	TAC083415A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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) 2023, the patient underwent an endovascular procedure to treat a dissection in zone 2- left common carotid artery (lcc) utilizing a gore® tag® thoracic branch endoprosthesis (aortic component and side branch) and gore® tag® conformable thoracic stent graft with active control system.Reportedly, there appears to be a retrograde type a dissection (rtad) from a proximal sine stent graft induced new entry tear on the approximate edge of the graft (aortic component).Its not propagating into the ascending, so not sure at this time if its a proximal sine or a rtad in the new entry tear.Patient came in last night (on (b)(6) 2023) with some pain and is currently stable and being monitored, it is not known if patient came in to emergency room or during a regular follow up to the hospital.Physician at some point plans to do a reintervention with open surgery to repair the dissection.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), possible adverse events and complications that may occur and/or require intervention include, but are not limited to dissection and reoperation.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ pre-implant and post-implant cta¿s available for evaluation.There is a dissection present on both pre-implant and post-operative.The proximal end of the graft is implanted at the level of the dissected tissue.The dissection has progressed more proximal in the arch when comparing the post-implant and the pre-implant images.There is an irregularity on one of the apices, it is flattened when compared to the others which have a slightly more pointed shape.No wire fracture is visualized.The tear appears to be inferior and lateral to the irregular apex, at the level of a fenestration.It is possible there is more than one fenestration visualized.It does appear the irregular apex is at the level of the dissected tissue and the proximal end of the graft was implanted in diseased/irregular tissue.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18378937
• Report Number: 2017233-2023-04505
• Device Sequence Number: 7712253
• Product Code: MIH
• UDI-Device Identifier: 00733132654093
• UDI-Public: 00733132654093
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/19/2024

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: 07/24/2026
• Device Catalogue Number: TAC083415A
• 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: 12/17/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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; Other
• Patient Age: 59 YR
• Patient Sex: Female