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

Catalog Number	TAC084015A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Clinical Endoleak (4843)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The fsa reported the following to gore: on (b)(6) 2024, the patient underwent an endovascular procedure to treat a chronic type b dissection utilizing the gore® dryseal flex introducer and gore® tag® thoracic branch endoprostheses (aortic and side branch component).The patient tolerated the procedure.Its was reported that at the time of the (b)(6) procedure, the physician felt that the primary entry tear was covered.However, on august 19th, 2024, the patient complained of back pain and received a ct.The physician decided to take the patient into surgery.A dacron graft was sown in the ascending aorta to the gore® tag® thoracic branch endoprosthesis and then the physician performed a bypass from the ascending graft to the innominate and carotid artery.An endoleak was present and it was determined to leave it alone.It may need to be treated in the future.The patient tolerated the procedure.
Additional Manufacturer Narrative
According to the gore® tag® thoracic branch endoprosthesis instructions for use, adverse events that may occur and / or require intervention include endoleak.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
Added d5, d6a, g3/g4, h1/h2, h6.According to the gore® tag® thoracic branch endoprosthesis instructions for use, adverse events that may occur and / or require intervention include dissection.The imaging evaluation determined the following: there were two time-points available for evaluation: pre-implantation computed tomography angiography (cta) dated (b)(6)2023, and post-implantation cta dated (b)(6)2024.The pre-implantation cta dated (b)(6)2023 shows: the primary entry tear is ~2mm, distal to the left subclavian artery (lsa).The length of dissected aorta appears to be ~22.8cm, by outer curve length.The ascending thoracic aorta is not dissected on the pre-implantation imaging.The covered length is 1.6cm, by outer curve length.The segment length is 2.1cm, by outer curve length.The proximal aortic diameters for the segment length appear to range from 35mm ¿ 39mm.The post-implantation cta dated (b)(6) 2024 shows: axial images show the ascending thoracic aorta is dissected from root to proximal implanted device.Lsa reconstruction images show contrast outside the implanted side branch(s).This finding suggests the possibility of a gutter leak.This contrast communicates with a large pooling of contrast in the false lumen.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20238092
• Report Number: 2017233-2024-05300
• Device Sequence Number: 8163533
• Product Code: MIH
• UDI-Device Identifier: 00733132654130
• UDI-Public: 00733132654130
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 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: 08/19/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2024
• 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 Sex: Male