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 TGMR373715J

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 07/03/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).It should be noted the gore® tag® conformable thoracic stent graft instructions for use (ifu) state ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, reoperation, and death.¿.

Event Description

On (b)(6) 2022, the patient underwent endovascular treatment of an aortic arch aneurysm using gore® tag® conformable thoracic stent graft with active control system.While advancing the proximal gore® tag® device, the device was reportedly stuck near the left subclavian artery.Using a snare, the physician reportedly secured the guidewire and pulled, and was able to advance the device.The device was delivered to the target location and was deployed just below the left common carotid artery.No ballooning was performed, and the procedure was completed without any further reported issues.The patient tolerated the procedure.Around 1am on (b)(6) 2022, the patient's condition reportedly worsened, and a ct scan revealed retrograde a type a aortic dissection (rtad) with an entry tear near the proximal edge of the gore® tag® device.It was reported the patient became bradycardic, experienced marked blood pressure decrease, and lost consciousness.The patient was transferred to the icu while cardiac massage was performed, but the patient was in cardiopulmonary arrest and died of right coronary artery ischemia due to rtad.According to the report, a review of intraoperative angiography images confirmed no evidence of rtad during the procedure.The physician reported that the rtad might have been caused by oversizing of the device.The report states the aorta diameter (average 34mm) was within the recommended range of the 37mm gore® tag® device; however, due to significant calcification and the diameter of the ascending aorta being greater than 40 mm, the patient was at high risk for rtad.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15117554
• MDR Text Key: 296747281
• Report Number: 2017233-2022-03166
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

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: TGMR373715J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/27/2022
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 87 YR
• Patient Sex: Female