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 TGM282810

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 12/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent endovascular treatment for a ruptured thoracic aortic aneurysm and was implanted with a gore® tag® conformable thoracic stent graft with active control system (ctag ac).The patient tolerated the procedure.On (b)(6) 2023, the physician reported the patient may possibly have a possible endoleak.Post review of the patient¿s computed tomography (ct), no obvious endoleak was seen.On (b)(6) 2023, the patient underwent follow-up ct was performed and the physician reports no obvious type i endoleak(s) were seen however he chose to re-intervene.The physician reported that during the procedure when placing a wire up the right iliac artery, he noticed that there was a problem with the wire going into the aorta.An angiogram was performed and determined a large aneurysm in the right common iliac artery (rcia), close to the aortic bifurcation.The ctag ac was extended with two additional ctag ac¿s both proximally and distally and the abdominal aorta and rciaa was treated with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.

Manufacturer Narrative

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.

• 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18457485
• MDR Text Key: 332255654
• Report Number: 2017233-2024-04523
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TGM282810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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): Required Intervention; Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Male