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

Catalog Number	TGU343415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu343415/(b)(4).(b)(4).
Event or Problem Description
On (b)(6) 2018, the patient underwent endovascular repair of an acute thoracic aortic dissection using a conformable gore® tag® thoracic endoprostheses.It was reported that computed tomography (ct) images dated (b)(6) 2018, revealed the entry tear was at the left subclavian artery as well as a penetrating ulcer in the dissection plane.While advancing the conformable gore® tag® thoracic endoprosthesis (tgu343415/17690331), during deployment the device advanced approximately 5mm covering the left carotid artery.The physician was able to use a gore® tri-lobe balloon catheter and pulled the device distally to uncover the left carotid artery.The left carotid artery was then patent.The physician then implanted an additional conformable gore® tag® thoracic endoprosthesis (tgu343415/18070192) distally and ballooned the overlap.The physician then implanted a 12mm amplatzer¿ vascular plug in the left subclavian artery and distal to the left vertebral artery.An angiogram taken from the brachial artery revealed the left vertebral artery was patent.Reportedly at the end of the procedure after the perclose proglide was utilized, the right foot was cold.The physician chose to open up the femoral artery and perform an endarterectomy.After the procedure, the femoral artery was patent and the foot had a pulse.The patient was then transferred to the intensive care unit of the hospital.On (b)(6) 2018, the patient had a major posterior stroke.The patient expired due to the stroke on (b)(6) 2018.The physician stated the patient¿s death is not a result of the gore® device.
Additional Manufacturer Narrative
Addition: code 213- the review of the manufacturing paperwork verified that these lots met all pre-release specifications.Addition: code 22- the conformable gore® tag® thoracic endoprosthesis instructions for use states that potential device or procedure related adverse events include endoprosthesis improper placement or migration, reoperation, and neurologic damage (e.G., stroke).

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7840468
• Report Number: 2017233-2018-00531
• Device Sequence Number: 1468925
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2018

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: 01/04/2021
• Device Catalogue Number: TGU343415
• Device Lot Number: 17690331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/01/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/19/2018
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 79