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

Catalog Number	TE3442A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® tag® thoracic branch endoprosthesis instructions for use (ifu) states: strict adherence to the gore® tag® thoracic branch endoprosthesis ifu sizing guide is required when selecting the appropriate size device components (tables 2 - 4).Appropriate oversizing of the gore® tag® thoracic branch endoprosthesis has been incorporated into the ifu sizing guide.Sizing outside of this range may result in endoleak, fracture, migration, device infolding, or compression.If aortic angulation is less than 60 degrees, or if there is significant calcium or thrombus, additional neck length may be required.Follow the recommendations of the instructions for use, carefully using the sizing guide (tables 2 - 4) and aortic screening measurements (figures 5-7).Additionally, the ifu states: possible adverse events and complications that may occur with the use of gore® tag® thoracic branch endoprosthesis include, but are not limited to: dissection, perforation, or rupture of the aortic vessel and/or surrounding vasculature, endoprosthesis: migration, surgical conversion, 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
On (b)(6) 2023, this patient underwent endovascular treatment of a zone 2 dissection and was implanted with gore® tag® thoracic branch endoprostheses (tbe).The physician states the gore® tag® thoracic branch aortic extender component (ae) initially deployed accurately; however from the time it took the team to remove the delivery catheter of the ae, and perform a final angiogram, the device had migrated aproximally, partially covering the left carotid artery.Once migration was noted, the physician accessed the patient¿s left carotid artery to place a stent and while doing so, noticed the patient had a retrograde type a dissection.The physician believes the retrograde type a dissection was caused by the proximal migration of the aortic extender.The patient¿s retrograde type a dissection was treated with open surgery.The patient tolerated the procedure.After reviewing images and sizing requirements with the physician it was determined that the likely cause of the migration was lack of proximal oversizing of the aortic extender.The patient¿s aorta measured 34mm at the proximal landing zone, which is larger than the maximum vessel diameter for a 34mm aortic extender.

• 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: 17840646
• Report Number: 2017233-2023-04310
• Device Sequence Number: 20628672
• Product Code: MIH
• UDI-Device Identifier: 00733132654314
• UDI-Public: 00733132654314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/28/2023

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: 01/22/2026
• Device Catalogue Number: TE3442A
• 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: 08/07/2023
• Initial Report FDA Received Date: 09/28/2023
• Date Device Manufactured: 01/24/2023
• 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; Hospitalization; Other
• Patient Sex: Female