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

Catalog Number	TE3140A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on friday (b)(6) 2024, the patient had a carotid to left subclavian bypass to treat a pseudoaneurysm on the inner curve of the aorta.On friday (b)(6) 2024, the patient was further treated for the pseudoaneurysm with gore® tag® thoracic branch endoprostheses, with the branch going into the left subclavian.After deployment, it was determined that they needed to extend proximally with an aortic extender.After deploying the extender, the angiography showed that the innominate artery was covered 30-40%.The physician advanced a coda balloon on the diagnostic wire from the pigtail, which had been located distal of the extender.The balloon was used in an attempt to dislodge the extender and move it distally, but this attempt failed.The physician then attempted to use a snare to pull the extender cuff distally.However, when this was attempted, the extender migrated quickly proximally, landing in the ascending aorta.This migration resolved the previous coverage issue; however, the extender did not have apposition against the vessel.Because the extender was highly likely to migrate, a bare metal stent was inserted to pin the extender against the vessel.No further interventions were performed at that time.The patient had no ongoing symptoms due to the event, and will be monitored.According to the physician, the device deployed correctly, and there was nothing wrong with the device.
Additional Manufacturer Narrative
H.6.Investigation findings code c21: conclusions pending results of product history review 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 findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic branch endoprosthesis may include, but are not limited to, improper stent graft placement and branch vessel obstruction.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19310702
• Report Number: 2017233-2024-04928
• Device Sequence Number: 20583851
• Product Code: MIH
• UDI-Device Identifier: 00733132654307
• UDI-Public: 00733132654307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/20/2024

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: 11/07/2025
• Device Catalogue Number: TE3140A
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/20/2024
• Date Device Manufactured: 11/09/2022
• 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