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 TGM343420J

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problem Ruptured Aneurysm (4436)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.H6: code c21 - results pending completion of product history review.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and / or require intervention include endoleaks and aortic expansion (aneurysm) and aortic rupture.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 was reported to gore: on may 18, 2022, the patient underwent an endovascular treatment of a thoracic aortic aneurysm using two gore® tag® conformable thoracic stent grafts with active control system.When a distal gore® tag® conformable thoracic stent graft with active control system was implanted, a wire was not following the greater curvature of the aneurysm but the wire was not able to be pushed because the patient was after taking a valve replacement.For clarification, the patient had undergone the valve placement before the initial procedure of ctag placement, so the physician hesitated to push the wire.The distal gore® tag® conformable thoracic stent graft with active control system was deployed where the distal landing length was 4cm.However after the implantation of the distal gore® tag® conformable thoracic stent graft with active control system, it moved proximally gradually and the distal landing length became 2 cm from 4 cm due to this migration.It was confirmed there was no endoleaks, so the procedure was concluded.On (b)(6) 2022, a ct revealed a minor distal type i endoleak.However, the patient denied an additional treatment, this endoleak was monitored.On (b)(6) 2023, the patient vomited up blood at his house.A reintervention was performed.A ct and an angiography didn¿t reveal an obvious aneurysm rupture, but it was considered it was high possibility that the aneurysm rupture occurred.And an intraoperative image showed that the distal gore® tag® conformable thoracic stent graft with active control system moved proximally about 3 cm and its distal end was into the aneurysm sac.Therefore, a gore® tag® conformable thoracic stent graft with active control system was implanted to treat the distal type i endoleak.The patient tolerated the procedure.Reportedly, the diameter of the thoracic aortic aneurysm was 58mm by ct on (b)(6) 2022, but the diameter became 67mm by ct on (b)(6) 2023.The aneurysm was enlarged.It was reported that the distal type i endoleak might have occurred due to the distal landing length becoming short during the initial procedure.

Manufacturer Narrative

Added e1, g3/g4, h1/h2.

Manufacturer Narrative

Section h6 - investigation conclusions: remove code d1002: adverse event related to procedure.

Manufacturer Narrative

H6: code c19: a review of the manufacturing records indicated the lot met all pre-release specifications.H6 code b15: images were provided, and an imaging evaluation was performed.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.The imaging evaluation determined the following: two images were received for evaluation.In image 1, there was a lack of wall apposition at the distal end of the implanted graft.There was contrast present outside of the graft.This was consistent with the reported distal type 1 endoleak.In image 2, there appeared to be an additional graft implanted and contrast was no longer visualized outside of the graft.Aneurysm rupture and migration was unable to be confirmed with the available image set.In addition, the images received could not be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.

Manufacturer Narrative

According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and / or require intervention include endoleaks and aortic expansion (aneurysm), aortic rupture and stent graft: migration.Device evaluation summary the device evaluation showed the following: no device evaluation could be performed as the delivery catheter, handles, and device were not returned for evaluation.Per the manufacturing product history review (phr), the device met all pre-release specifications, and at the time of manufacturing, there were no capas or ncrs related to this event.The imaging evaluation showed that there is contrast outside of the graft which is consistent with the reported distal type i endoleak.A root cause for the device migration cannot be confirmed with the currently available information.The type i endoleak may have been a result of the device migration.Based on this investigation, there is no evidence to suggest a manufacturing deficiency.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18296374
• MDR Text Key: 330083564
• Report Number: 2017233-2023-04459
• 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,Followup,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: TGM343420J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male