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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Embolism (1829); No Code Available (3191)

Event Date 08/30/2020

Event Type  Death  

Manufacturer Narrative

As it is unknown which gore® tag® thoracic endoprosthesis may have caused or contributed to the reported event, the following component will be included on this report: tgu373710j / 18758913.(b)(4).It should be noted that, per the gore® tag® conformable thoracic stent graft instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to embolism (micro and macro) with transient or permanent ischemia, and death.Additionally, the safety and effectiveness of the gore® tag® conformable thoracic stent graft have not been evaluated in patients with previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® conformable thoracic endoprosthesis, gore® tag® conformable thoracic stent graft with active control system, and a gore® dryseal flex introducer sheath.The ¿pull-through¿ technique between the right brachial artery and the left common femoral artery was used because the site of the existing elephant trunk graft in the transverse aorta was severely tortuous.Percutaneous transluminal angioplasty (pta) was performed to the left common femoral artery because the access vessel was reportedly calcified.The 22fr sheath was advanced from the left common femoral artery up to the level of the elephant trunk, but reportedly would not cross the anastomosis site due to vessel tortuosity.According to the report, the gore® tag® conformable thoracic stent graft with active control system was advanced outside the sheath and was successfully navigated through the anastomosis site.The gore® tag® conformable thoracic stent graft with active control system was implanted successfully at the target location.The gore® tag® conformable thoracic endoprosthesis was then successfully implanted distally.The procedure was concluded without any further reported complications.The patient tolerated the procedure.On (b)(6) 2020, the patient¿s condition reportedly declined.It was reported the patient¿s blood pressure and breathing were not able to be controlled.On (b)(6) 2020, follow-up ct imaging reportedly revealed occlusion of the left hepatic artery, splenic infarction, and stenosis of a hemodialysis shunt in the left arm.On (b)(6) 2020, the patient expired due to multiple organ failure.According to the physician, manipulation of the sheath with excessive force across the anastomosis site may have caused an embolic shower; however, this opinion could not be verified by ct imaging or blood examination.

Manufacturer Narrative

G5: added pma/510(k) number; h6: results and conclusion coding updated; h6: code 213 : a review of the manufacturing records for the device verified that the lot met all pre-release specifications.It should be noted that, per the gore® tag® conformable thoracic stent graft instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to embolism (micro and macro) with transient or permanent ischemia, and death.Additionally, the safety and effectiveness of the gore® tag® conformable thoracic stent graft have not been evaluated in patients with previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.

• 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
• MDR Report Key: 10607170
• MDR Text Key: 209190867
• Report Number: 2017233-2020-01309
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Catalogue Number: TGMR373720J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR