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

Catalog Number	TGU343420
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak, aortic expansion, and reoperation.
Event or Problem Description
On (b)(6) 2016, this patient underwent a repair of a thoracoabdominal aortic aneurysm whereby two conformable gore® tag® thoracic endoprostheses were implanted in zone 4 of the thoracic aorta.Two stents were also reportedly implanted in the celiac and superior mesenteric arteries.Pre-treatment computed tomography angiography (cta) showed that the maximum diameter of aortic aneurysm/lesion was 66mm.The patient tolerated the initial procedure.From (b)(6) 2016 till (b)(6) 2016, the follow up computed tomography angiography (cta) showed that the maximum diameter of aortic aneurysm/lesion was 70mm.On (b)(6) 2018, the follow up cta determined that the maximum diameter of aortic aneurysm/lesion was 76mm.Additionally, on (b)(6) 2018, a proximal type i endoleak associated with a tgu343420/14653201 was identified.On (b)(6) 2018, the reintervention was performed whereby an additional aortic endograft was implanted.
Additional Manufacturer Narrative
Corrected information: event date.

• 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: 7981539
• Report Number: 2017233-2018-00627
• Device Sequence Number: 11020333
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 11/22/2018
• Device Catalogue Number: TGU343420
• Device Lot Number: 14653201
• 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: 10/18/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 88