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

Catalog Number	TGU282810
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); No Information (3190)
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: surgical conversion.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) 2017, this patient was implanted with a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2018, gore medical device tracking received documentation from the implanting hospital that the device had been explanted and discarded at the site.The date and reason for explant was not provided.Further investigation is underway.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment of a type a aortic dissection complicated with renal malperfusion and lower extremity malperfusion and fenestration and stenting with a conformable gore® tag® thoracic (ctag) endoprosthesis.The patient developed renal failure post operatively but recovered and regained kidney function.The patient tolerated the procedure.On (b)(6) 2018, the patient underwent reintervention for rapidly expanding proximal descending aneurysm which had enlarged from 4.8cm to 6.5cm and a celiac artery aneurysm which measured 4.7cm.Thoracoabdominal aneurysm repair was performed and the ctag device was explanted and the arch was repaired with a 28mm multi branch graft.The aorta was then dissected from the left subclavian artery down to the infrarenal aorta to the renal arteries using 4 separate dacron grafts.The patient tolerated the procedure.

• 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: 7719604
• Report Number: 2017233-2018-00453
• Device Sequence Number: 904542
• Product Code: MIH
• UDI-Device Identifier: 00733132618026
• UDI-Public: 00733132618026
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 05/25/2019
• Device Catalogue Number: TGU282810
• Device Lot Number: 15175388
• 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: 07/25/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 59 YR