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

Catalog Number	TGU454515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to aneurysm rupture and death.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2017 a patient underwent treatment of a thoracic aortic aneurysm, zone 2, measuring 46.2mm, with gore® tag® thoracic branch endoprostheses and a conformable gore® tag® thoracic endoprosthesis.It was reported all devices were implanted in the desired locations and all components were patent, as demonstrated by angiography at the end of the procedure.On (b)(6) 2017 the patient had a ct which showed a type ii endoleak, from the intercostal arteries, associated with the investigational gore® tag® thoracic branch endoprosthesis aortic component.The maximum total diameter of the aneurysm was 53.1mm.On (b)(6) 2019 the patient presented to the emergency department with acute sharp chest pain.A cta was performed which was concerning for an endoleak.It showed a new type b dissection which was at the distal tip of the ctag device with retrograde flow into the false lumen, but no evidence of rupture.On (b)(6) 2019 the patient went into sudden cardiac arrest and return of spontaneous circulation (rosc) could not be accomplished.The patient had a presumed rupture of the aortic aneurysm and expired.Had the patient not expired so suddenly, the plan would have been to extend coverage distally.

• 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: 8489780
• Report Number: 2017233-2019-00223
• Device Sequence Number: 19501106
• Product Code: MIH
• UDI-Device Identifier: 00733132618200
• UDI-Public: 00733132618200
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 06/01/2020
• Device Catalogue Number: TGU454515
• Device Lot Number: 16438610
• 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
• Initial Report FDA Received Date: 04/06/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75