MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM

Model Number	TGU313115
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted device (b)(4) was requested for analysis, however, it is not available as it was sent to pathology.Also were used: (b)(4).Please note that these devices remained implanted.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events which may require intervention, and / or conversion to open repair include, but are not limited to aneurysm enlargement and aneurysm rupture.The date of event will be used (b)(6) 2015, when the follow-up cta showed that the aneurysm enlarged.
Event or Problem Description
On (b)(6) 2015, a patient underwent a descending thoracic aortic aneurysm treatment using conformable gore® tag® thoracic endoprostheses.Reportedly, the devices were placed in the zone 4 (distal descending thoracic aorta).Patient tolerated the procedure.It was reported that the patient had a history of the open visceral debranching procedure.Pre-treatment computed tomography angiography (cta) showed that the maximum diameter of an aortic aneurysm/lesion was 60mm.On (b)(6) 2015, the follow-up cta showed that the was 73mm.On (b)(6) 2016, the maximum diameter of an aortic aneurysm/lesion was 53mm.On (b)(6) 2017, the maximum diameter of an aortic aneurysm/lesion was 55mm.From (b)(6) 2018 to (b)(6) 2020, the maximum diameter of an aortic aneurysm/lesion increased in size from 49mm to 63mm.Reportedly, on (b)(6) 2020, the patient had an expansion of the distal descending thoracic aorta with the rupture into the right crus of the diaphragm.According to the information provided, the physician believed that a type v endoleak caused the aneurysm enlargement, and the aneurysm rupture at the treated segment of the thoracic aortic aneurysm into the level of the right crus of the diaphragm.On (b)(6) 2020, the (b)(4) device was explanted.Reportedly, on (b)(6) 2020, the patient expired due to the acute respiratory failure, unrelated to the device or procedure.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10538539
• Report Number: 2017233-2020-01264
• Device Sequence Number: 19681818
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2018
• Device Model Number: TGU313115
• Device Catalogue Number: TGU313115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 51