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

Catalog Number	TSB081506A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent a thoracic endovascular aortic repair (tevar) procedure in zone 3 left subclavian artery (lsa) to treat a type b dissection and intramural hematoma utilizing a gore® tag® thoracic branch endoprosthesis (side branch and aortic component).Reportedly, during the procedure, the side branch was deployed too high and ended up fully covering the left vertebral artery.Physician tried to pull it down with a 8mm balloon but did not work and they decided to open up the patient's chest as they assumed there was retrograde type a dissection (rtad) due to the occlusion.Once the patient was opened up, the physician was able to tug the graft down interoperable and open up the left vertebral artery again with no retrograde type a dissection, no blood flow issues and patient tolerated the procedure.2200-e:-vessel coverage - other/unknown is used to capture the unintentional coverage of the left vertebral artery by the endograft.5400-c additional procedure other - other/unknown is used to capture the open surgery to pull the graft down from the occluded left vertebral artery.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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 branch vessel occlusion or obstruction.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
D12 known inherent risk of device and information for use statement.
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent a thoracic endovascular aortic repair (tevar) procedure to treat a type b dissection and intramural hematoma utilizing a gore® tag® thoracic branch endoprosthesis (side branch and aortic component) in zone 2.Imaging for this case was requested but not available.Reportedly, during the procedure, the side branch was deployed too high and ended up fully covering the left vertebral artery.The device was deployed in parallax therefore making it difficult to ensure alignment with the tbe ac and sb components as well as the location of the left vertebral artery.Physician tried to pull it down endovascularly with an 8mm balloon but it did not work.They decided to open up the patient's chest as they assumed there was retrograde type a dissection (rtad) as a result of trying to pull the device down with the balloon.Once the patient was opened up, the physician was able to tug the graft down intraoperatively and provide flow to the left vertebral artery again.There was no retrograde type a dissection, no remaining blood flow issues, and the patient tolerated the procedure.2200-e:-vessel coverage - other/unknown is used to capture the unintentional coverage of the left vertebral artery by the side branch device.5400-c additional procedure other - other/unknown is used to capture the open surgery required to pull the side branch device down from the unintentionally covered left vertebral artery.

• 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: 18870799
• Report Number: 2017233-2024-04690
• Device Sequence Number: 16883533
• Product Code: MIH
• UDI-Device Identifier: 00733132654383
• UDI-Public: 00733132654383
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 03/12/2024

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: 06/11/2026
• Device Catalogue Number: TSB081506A
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 87 KG