MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TAG2810

Device Problem Collapse (1099)

Patient Problems High Blood Pressure/ Hypertension (1908); Claudication (2550)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork for the device verified that the lot met all pre-release specifications.Tag2810/10176117 (b)(4).Images and the additional information were requested to confirm procedural details of the reintervention repair.Further information will be provided.

Event Description

The patient referenced in this event file is enrolled in a (b)(6) registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the (b)(6).(b)(6) is the clinical study database (csd), capturing the data through the grt 10-11 module.It was reported that on (b)(6) 2013, the patient was a victim of an automobile accident, with blunt chest and pelvis trauma.On an unknown date, the patient developed a lesion in the descending thoracic aorta.On (b)(6) 2013, the patient was implanted with a gore tag thoracic endoprosthesis to treat a descending thoracic aorta rupture.The device was deployed in zone 3.The pre-treatment computed tomography angiography (cta) determined that the maximum diameter of the aortic aneurysm/lesion was 30mm.Reportedly, there was no vascular intervention before this procedure the patient tolerated the procedure and was discharged from the hospital on (b)(6) 2013.On (b)(6) 2014, a follow-up ct showed no change in the maximum diameter of the aortic aneurysm/lesion.On (b)(6) 2015, a follow-up ct demonstrated a decrease in maximum diameter of the aortic aneurysm/lesion of 27mm.It was reported that on (b)(6) 2016, a collapse of the device was identified.The physician reported the cause of the device collapse is unknown.It was reported the aorta had not dilated, there was no evidence of calcified thrombus present in the aorta, and device sizing was within ifu guidelines.On (b)(6) 2016, a reintervention was completed to treat the device collapse whereby a medtronic device (32x32x150 mm) was implanted at the left subclavian artery.The patient was discharged on (b)(6) 2016 after being treated for a hypertension and claudication of the lower limbs.On an unknown date, a follow-up ct scan revealed the collapse of the medtronic device.On (b)(6) 2016, an additional procedure was performed.Further procedure details are unconfirmed.However, it was reported the previous implanted devices were fully reopened.Images and the additional information were requested to confirm procedural details of the reintervention repair.

Manufacturer Narrative

Event description.Medical conditions.Despite multiple requests, images were not provided.Based on the available information the root cause cannot be determined.The gore tag thoracic endoprosthesis instructions for use (ifu) states that the gore tag thoracic endoprosthesis provides endovascular repair of aneurysms of the descending thoracic aorta (dta).The safety and effectiveness of the gore tag thoracic endoprosthesis have not been evaluated in the following patient etiology: traumatic aortic transections.Additionally, according to the gore tag thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore tag thoracic endoprosthesis may include but are not limited to reoperation.

Event Description

It was reported that on (b)(6) 2013, the patient was a victim of an automobile accident, with blunt chest and pelvis trauma.Also, the patient developed a small lesion (laceration) in the descending thoracic aorta.On (b)(6) 2013, the patient was implanted with a gore tag thoracic endoprosthesis to treat a descending thoracic aorta rupture.The device was deployed in zone 3.The pre-treatment computed tomography angiography (cta) determined that the maximum diameter of the aortic aneurysm/lesion was 30mm.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2013.On (b)(6) 2014, a follow-up ct showed no change in the maximum diameter of the aortic aneurysm/lesion.On (b)(6) 2015, a follow-up ct demonstrated a decrease in maximum diameter of the aortic aneurysm/lesion of 27mm.On an unknown date in 2016, the patient began to show elevations in blood pressure without a good control with medication.The patient was not diagnosed with hypertension previously.It was reported that on (b)(6) 2016, a collapse of the device was identified.The physician reported the cause of the device collapse is the device has lost anchor within the aorta, causing a significant stenosis.It was reported the aorta had not dilated, there was no evidence of calcified thrombus present in the aorta, and device sizing was within ifu guidelines.On (b)(6) 2016, after catheterization and ballooning of the gore tag thoracic endoprosthesis, a reintervention was completed to treat the device collapse whereby a medtronic device (32x32x150 mm) was implanted at the origin of the left subclavian artery covering the entire gore device to anchor the distal thoracic aorta.The cta showed correction of the collapse.The patient progressed well and was discharged on (b)(6) 2016.On an unknown date, after discharge from the hospital, the patient developed hypertension and claudication of the lower limbs.On an unknown date, a follow-up ct scan revealed the collapse of the medtronic device.The stent lost anchor and presented a significant stenosis.Reportedly, gore tag thoracic endoprosthesis had positioned properly.On (b)(6) 2016, an additional procedure was performed.After an aortoplasty, three coated stents were positioned inside the medtronic device.It was reported the previous implanted devices were fully reopened.The patient tolerated the procedure.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6008148
• MDR Text Key: 56768477
• Report Number: 2017233-2016-00777
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

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 Expiration Date: 02/28/2015
• Device Catalogue Number: TAG2810
• Device Lot Number: 10176117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 85