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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Vascular Dissection (3160); Ruptured Aneurysm (4436)

Event Date 12/08/2021

Event Type  Death  

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an aortic arch aneurysm using a 37mm x 20cm gore® tag® conformable thoracic stent graft with active control system.According to the physician, the distal end of the device was slightly oversized but within the acceptable range (distal landing zone measured a reported 27.2mm to 29.3mm in diameter).The gore® tag® device was placed without any reported issues.When the device was ballooned at the distal end to achieve seal, overdilation of the balloon was suspected (volume of balloon inflation not reported).However, no issue was observed on the confirmation angiograph, and there was no reported change in the patient's blood pressure.The patient tolerated the procedure.Upon awakening from anesthesia after admission to an intensive care unit room, the patient complained of chest discomfort and chest pain.A dissection was suspected, and computed tomography imaging reportedly confirmed a distal stent graft-induced new entry (dsine) and rupture at the site.An emergent endovascular treatment was performed, and an additional stent graft was placed with overlap of about 50mm on the distal end of the device.A confirmation angiograph after ballooning reportedly showed an endoleak at the overlap site.When additional ballooning was performed, cardiac arrest reportedly occurred.According to the report, cardiac massage was performed, but abdominal echocardiography showed a hematoma, and rupture of an abdominal aortic aneurysm was suspected.The patient subsequently died.The physician reported that the dsine was probably caused by a device with an oversized distal end.The physician also commented that the distal end of the gore® tag® device being shorter than expected and landing in an aneurysmal region of the thoracic aorta, and overdilation during the ballooning, may also have contributed to this event.It was also reported that hemodynamic changes in the thoracic aorta may have led to rupture of the existing abdominal aortic aneurysm, although this rupture could not be confirmed.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted the gore® tag® conformable thoracic stent graft with active control system 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, aortic rupture, reoperation, and death.¿ additionally, per ifu, strict adherence to the gore® tag® conformable thoracic stent graft ifu sizing guide is required when selecting the appropriate device size (intended aortic diameter for a 37mm x 20cm gore® tag® conformable thoracic stent graft is 29-34mm).The gore® tag® conformable thoracic stent graft is designed to be oversized from 6 to 33%.Appropriate device oversizing has been incorporated into the ifu sizing guide.

• 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: 13118402
• MDR Text Key: 282973144
• Report Number: 2017233-2021-02651
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

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: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Male