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

Catalog Number	TSB121706A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.The instructions for use (ifu) states, the gore® tag® thoracic branch endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who have adequate anatomy.Additional device associated with this event: tsb121706a/(b)(6), udi: (b)(4).
Event or Problem Description
On (b)(6) 2024, this patient underwent endovascular treatment for an ascending aortic aneurysm.The patient was implanted with gore® tag® thoracic branch endoprostheses (tbe) in zone 0 and with a proximal extension into the ascending aorta using gore® tag® conformable thoracic stent grafts (ctag).The patient tolerated the procedure.The tbe side branch devices were implanted within the brachiocephalic artery.On (b)(6) 2024, the physician reported the patient had a pseudoaneurysm at the distal end of the side branch devices.Onset date is unknown, physician suspects the patient may have developed an infection, but this has not been confirmed.On (b)(6) 2024, it was reported that the patient is believed to have also developed a small penetrating aortic ulcer (pau) in the ascending aorta proximal to the ctag device.The fsa is not aware of any planned intervention to treat this pau.On (b)(6) 2024, the patient underwent endovascular reintervention for treatment of the pseudoaneurysm at the distal end of the side branch device.An additional gore® tag® thoracic branch endoprosthesis side branch was implanted in the brachiocephalic artery.The patient tolerated the procedure with good results.
Additional Manufacturer Narrative
Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: two cta¿s submitted for evaluation, both have arterial phase only, non-contrast and delay phases are not available for evaluation.There is a lack of wall apposition at the distal end of the side branch.There is a contrast-like density outside of the graft near the distal end of the side branch.Contrast cannot be confirmed with an arterial phase only image set.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19337696
• Report Number: 2017233-2024-04938
• Device Sequence Number: 8693819
• Product Code: MIH
• UDI-Device Identifier: 00733132654413
• UDI-Public: 00733132654413
• Combination Product (Y/N): Y
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 06/28/2026
• Device Catalogue Number: TSB121706A
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male