MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGT3420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: endoleak a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for a thoracic aortic dissection and was implanted with two gore® tag® thoracic endoprostheses.Final imaging was reported to show a potential distal type i endoleak remained.The physician chose conclude the procedure and monitor the patient.The patient tolerated the procedure.On an unknown date follow up imaging showed no endoleak.On an unknown date estimated to be on or about (b)(6) 2019, computed tomography imaging showed a distal type i endoleak.On (b)(6) 2019, the patient underwent reintervention for treatment of the distal type i endoleak and an additional conformable gore® tag® thoracic endoprosthesis was implanted distally to extend coverage.The patient tolerated the procedure.The physician believes possible migration may have caused or contributed to the distal type i endoleak; however the information provided was not sufficient to determine a cause.
Additional Manufacturer Narrative
Event: corrected/additional information.
Event or Problem Description
Problem on (b)(6) 2013, this patient underwent endovascular treatment for a thoracic aortic aneurysm.
Additional Manufacturer Narrative
B5: corrected/additional information.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8376512
• Report Number: 2017233-2019-00114
• Device Sequence Number: 1332878
• Product Code: MIH
• UDI-Device Identifier: 00733132613656
• UDI-Public: 00733132613656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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: 01/31/2016
• Device Catalogue Number: TGT3420
• Device Lot Number: 11137059
• 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: 02/27/2019
• Supplement Report FDA Received Date: 03/26/2019; 03/26/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 86 YR