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	TGMR404010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, patient was treated for a descending thoracic aneurysm utilizing gore® tag® conformable thoracic stent graft with active control system (ctagac).On (b)(6) 2022, patient was also treated for an abdominal aortic aneurysm utilizing gore® excluder® conformable aaa endoprosthesis.On (b)(6) 2024, upon reviewing a ct for this patient, a distal type 1b endoleak was observed on ctagac device tgmr404010.It is unknown if there was any aneurysm growth.The cause of this endoleak remains unknown.It was later reported that on (b)(6) 2024, patient underwent a reintervention procedure.During the procedure, the physician was unable to get a 22fr sheath due to small access.Physician was aware of this going into the procedure.Physician implanted a 8mmx39mm gore® viabahn®vbx balloon expandable endoprosthesis in the left external iliac.Physician still was not able to get sheath or graft in.Physician attempted to put in a ctagac device, but was not able to implant due to small access.Physician is bringing patient back for another procedure to do a cutdown and sew a conduit to her common iliac artery, as a means to be able to get the device in.On (b)(6) 2024, patient underwent surgery.Physician extended prior ctagac device with another 40mmx15cm ctagac device.Patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code c21 - results pending completion of product history review.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® tag® conformable thoracic stent graft with active control instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.Patient medical history includes: high cholesterol; thyroid disease; copd; primary hypertension.Patient medication includes: sertaline hcl; metroprolol succinate; methotrexate; lisinopril; levothyroxine sodium; aspirin; atenolol.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
Updated section g3/g4.Updated section h6.H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.
Additional Manufacturer Narrative
Updated section g3/g4, h2, and h10.Images were provided.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time-point available for evaluation: post-implantation cta dated 7/09/2024.¿ there is contrast outside the distal end of the implanted gore® tag® conformable thoracic stent graft.¿ there is lack of distal device apposition, thereby, confirming the distal type i endoleak.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20064568
• Report Number: 2017233-2024-05264
• Device Sequence Number: 7784451
• Product Code: MIH
• UDI-Device Identifier: 00733132646838
• UDI-Public: 00733132646838
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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,Followup
• Report Date (Section B): 10/07/2024

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: 08/01/2024
• Device Catalogue Number: TGMR404010
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024; 09/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/17/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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
• Patient Sex: Female
• Patient Weight: 52 KG