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 TGMR404015J

Device Problem Unintended Movement (3026)

Patient Problem Vascular Dissection (3160)

Event Date 02/16/2024

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent an endovascular treatment of a type b aortic dissection using gore® tag® conformable thoracic stent graft with active control system(ctag/ac).Reportedly, the procedure went well with two ctag/ac devices being implanted with no issues and the patient tolerated the procedure.On an unknown date, a bird beak and a migration approximately 20mm distally on the proximal side of the proximally implanted ctag/ac were observed as well as a new tear(d-sine) at the distal side of the distally implanted ctag/ac and a distal type i endoleak.On february 16, 2024, a reintervention was performed, two additional stent grafts were placed to extend the proximal and distal implantation site.The endoleak was reportedly resolved and the patient tolerated the procedure.It was reported that these events might have been caused by a significant change in vascular geometry due to the remodeling.

Manufacturer Narrative

Investigation findings code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Type of investigation: code b20: the device remains implanted and was therefore not available for engineering evaluation.H.6.: investigation conclusions: code d12: it should be noted that, per the gore® tag® conformable thoracic stent grafts with active control system instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to,endoleak, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, and reoperation.Complications associated with the use of the gore® tag® conformable thoracic stent graft with active control system may include but are not limited to: aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), stent graft: improper placement, migration.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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18899691
• MDR Text Key: 337618325
• Report Number: 2017233-2024-04709
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: TGMR404015J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 10/14/2020
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male