MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGMR373715J

Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 11/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient underwent an endovascular procedure to treat a thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system.Reportedly, 1 debranch bypass for the left subclavian artery was performed at the same time, and the device was implanted from the zone 2.On an unknown date, a proximal type i endoleak due to the device migration was confirmed.The aneurysm enlargement was also observed.On (b)(6) 2022, a reintervention was performed.After the bypass surgery for the left common carotid artery was performed, an additional stent graft was implanted from the zone 1.The endoleak was resolved, and the procedure was completed.Reportedly, the device migration occurred due to a short proximal landing zone at the index procedure.Additional information was requested, however, no information obtained regarding the proximal landing zone length, the amount of the migration and aneurysm enlargement.

Manufacturer Narrative

(b)(4).The device remains implanted and is not available for investigation.As the day of the follow up examination where a type i endoleak/device migration/aneurysm enlargement were detected is unknown, (b)(6) 2022 is used as an event date.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.

Manufacturer Narrative

H6: code c19- a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Additional information was requested, however, no information obtained regarding the proximal landing zone length, the amount of the migration and aneurysm enlargement.Reportedly, the device migration occurred due to a short proximal landing zone at the index procedure.According to the gore® tag® conformable thoracic stent graft instructions for use (ifu), the gore® tag® conformable thoracic stent graft is intended for endovascular repair of all lesions of the descending thoracic aorta in patients who have appropriate anatomy, including: = 20 mm non-aneurysmal aorta proximal and distal to the lesion.The ifu states: key anatomic elements that may affect successful treatment of the lesion include severe neck angulation, short aortic neck(s) and significant thrombus and / or calcium at the arterial implantation sites.In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Additionally, complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), endoleak, stent graft migration and reoperation.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15784945
• MDR Text Key: 303559470
• Report Number: 2017233-2022-03474
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: TGMR373715J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male