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 TGMR373720J

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Vasodilatation (2127)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

H.6.: code b22: results pending completion of investigation.H.6.: code c21: results pending completion of investigation.H.6.: d16: conclusion not yet available.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 Description

The following information was reported to gore: on (b)(6) 2022, this patient underwent emergency endovascular treatment of a ruptured distal arch aneurysm using gore® tag® conformable thoracic stent graft with active control system (ctag-ac device).The left subclavian artery was embolised and the ctag-ac device was implanted from zone 2.On an unknown date, during follow-up, migration of the ctag-ac device to the distal side was identified.Reportedly, proximal neck dilation was also observed.No aneurysm enlargement or apparent endoleak was observed.On (b)(6) 2024, a reintervention was performed, and an additional stent graft (with fenestration in the brachiocephalic artery and left common carotid artery, non-gore stent graft) was implanted from (b)(4).The physician reportedly stated as follows: the aneurysm originally protruded significantly to the greater curvature of the distal arch and was also flexed in three dimensions, making it easy for the ctag-ac device to be pulled into the space.It is also possible that the landing length was slightly insufficient at the initial procedure.During the initial procedure, only one ctag-ac device was implanted because it was emergency, but i believe that two devices would have been implanted if it had not been an emergency.

Manufacturer Narrative

H.6.: investigation findings: code c21, updated to code c19.A review of manufacturing records verified, that the lot involved in this complaint met all pre-release specifications.H.6.: type of investigation: code b22, updated to b20.Device remains implanted.And therefore, not available for direct analysis.H.6.: investigation conclusions: code d16, updated to d12.According to the gore® tag® conformable thoracic stent graft with active control system instructions, for use (ifu): potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to access, delivery and deployment events (e.G.Access failure, deployment difficulties/failures, failure to deliver the stent graft and insertion or removal difficulty) as well as, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), dissection/perforation/rupture of the aortic vessel & surrounding vasculature, persistent false lumen flow 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86001 ; 9285263030
• MDR Report Key: 19102723
• MDR Text Key: 340102943
• Report Number: 2017233-2024-04817
• 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,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TGMR373720J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/13/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 Sex: Male