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

Catalog Number TGC404015

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 04/04/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).The patient¿s medications include; acetaminophen, clonazepam, dihydrocodeine, hydrocodone, citalopram, escitalopram and diphenhydramine.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The root cause of the acute type a dissection with rupture, resulting in the patient¿s death could not be determined with the information provided.

Event Description

The following information was reported to gore through the (b)(6) study for evaluation of the conformable gore tag thoracic endoprosthesis for treatment of aneurysm of the descending thoracic aorta.On (b)(6) 2010, the patient underwent treatment of a fusiform (> 50mm) aneurysm in the descending thoracic aorta with two conformable gore tag thoracic endoprostheses.It was reported the left subclavian artery, was not covered during the implant procedure.No significant blood loss was reported and a transfusion was not required.The procedure concluded with no deployment issues being reported.Final angiography confirmed exclusion of the aneurysm and the patient tolerated the procedure.It was reported post operatively the patient was treated with a cerebrospinal fluid drain to prevent paraplegia.On (b)(6) 2013, follow-up computed tomography (ct) images identified a maximum aneurysm diameter of 46.4 mm, with no evidence of endoleak, device migration, wire fracture or rupture.On (b)(6) 2014, it was reported the patient suffered an acute type a dissection with rupture, resulting in the patient's death.Based on the autopsy report, no abnormalities were seen in the treated segment of the descending thoracic aorta, reportedly the treated segment remained intact.The area of acute rupture involved the ascending arch proximal to the previously placed conformable gore tag thoracic endoprosthesis.It was reported, the patient suffered an acute type a dissection in the ascending arch resulting in cardiac tamponade.The adverse event was reported to have occurred at the patient's home, the patient was not hospitalized at the time of his death.

• 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5943751
• MDR Text Key: 54502039
• Report Number: 2017233-2016-00746
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: TGC404015
• Device Lot Number: 7511610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2010
• 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): Death; Other
• Patient Age: 69 YR
• Patient Weight: 82