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

Model Number	TGM454510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/31/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The safety and effectiveness of the gore® tag® conformable thoracic stent graft have not been evaluated in the following patient etiologies including previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.In addition, the ifu states that complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to aortic rupture and death.Care should be taken not to balloon outside of the gore® tag® conformable thoracic stent graft.Ballooning native vessel could lead to vessel damage, rupture, or death.
Event or Problem Description
On (b)(6) 2020, this patient underwent an endovascular procedure whereby a conformable gore® tag® thoracic endoprosthesis with active control was implanted in the thoracic aorta, proximally to a previously implanted cook® custom made device, to treat a suspected endoleak of unknown origin.It is unknown for what pathology the cook® custom made device was implanted.Measurements of the thoracic aorta were not provided.After deploying the gore® tag® device, the physician performed ballooning (balloon manufacturer unknown).Upon ballooning, the thoracic aorta ruptured.Two additional conformable gore® tag® thoracic endoprosthesis with active control devices were implanted proximally.However, the patient did not recover and expired.
Additional Manufacturer Narrative
Additional information/corrected data.Section a: patient information.Additional narrative: the reason for the cook implant was due to a paraviceral aneurysm.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10621644
• Report Number: 2017233-2020-01324
• Device Sequence Number: 19490734
• Product Code: MIH
• UDI-Device Identifier: 00733132646982
• UDI-Public: 00733132646982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: TGM454510
• Device Catalogue Number: TGM454510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR