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

Catalog Number	TGU454520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
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 (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reoperation.
Event or Problem Description
On (b)(6) 2016 a patient underwent treatment of a 60mm thoracic aortic aneurysm, zone 3, with two conformable gore® tag® thoracic endoprostheses.On an unknown date in (b)(6) 2018 the patient was hospitalized and underwent an additional endovascular procedure with additional stent placement.
Additional Manufacturer Narrative
Additional device information: tgu454510, lot # 14209635.Udi: (b)(4).It is not known which device was involved, therefore both were investigated.
Additional Manufacturer Narrative
Event updated.
Event or Problem Description
On (b)(6), 2016 a patient underwent treatment of a 60mm thoracic aortic aneurysm, zone 3, with two conformable gore® tag® thoracic endoprostheses.On an unknown date in october, 2018 the patient was hospitalized for aneurysm enlargement noted on ct to measure 6.5cm.The aneurysmal region started at the level of a previously implanted thoracic aortic stent and extended distally to the aortic bifurcation.The aneurysm involved the celiac axis, superior mesenteric artery and her single right side renal artery and underwent an additional endovascular procedure with additional stent placement.She was referred to mayo clinic for endovascular repair using a fenestrated branched stent graft.On (b)(6), 2018, the patient underwent endovascular placement of a branched fenestrated device, for an extent type 2 thoracoabdominal aortic aneurysm using a patient specific directional branched stent graft.A proximal custom low-profile thoracic stent graft, 46mm x 32mm x 210mm component was placed with 3 directional branches.The celiac axis and superior mesenteric artery were both branched with gore® viabahn® vbx balloon expandable endoprostheses.The renal artery was branched with a both a gore® viabahn® endoprosthesis and an i-cast stent.The proximal and distal landing zones were ballooned and the patient tolerated the procedure.
Additional Manufacturer Narrative
B.5.Updated.H.6.Conclusion code 1: 22: according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to endoleak, aortic expansion and reoperation.
Event or Problem Description
On (b)(6) 2016 a patient underwent treatment of a 60mm thoracic aortic aneurysm, zone 3, with two conformable gore® tag® thoracic endoprostheses.On (b)(6) 2018 the patient was hospitalized for aneurysm enlargement noted on ct to measure 6.5cm.The aneurysmal region started at the level of a previously implanted thoracic aortic stent and extended distally to the aortic bifurcation.The aneurysm involved the celiac axis, superior mesenteric artery and her single right side renal artery and underwent an additional endovascular procedure with additional stent placement.She was referred to mayo clinic for endovascular repair using a fenestrated branched stent graft.On an unknown date the patient underwent endovascular placement of a branched fenestrated device, for an extent type 2 thoracoabdominal aortic aneurysm using a patient specific directional branched stent graft.A proximal custom low-profile thoracic stent graft, 46mm x 32mm x 210mm component was placed with 3 directional branches.The celiac axis and superior mesenteric artery were both branched with gore® viabahn® vbx balloon expandable endoprostheses.The renal artery was branched with a both a gore® viabahn® endoprosthesis and an i-cast stent.The proximal and distal landing zones were ballooned and the patient tolerated the procedure.
Additional Manufacturer Narrative
B.5.Updated dates.
Event or Problem Description
On (b)(6) 2016 a patient underwent treatment of a 60mm thoracic aortic aneurysm, zone 3, with two conformable gore® tag® thoracic endoprostheses.On an unknown date in (b)(6) 2018 the patient was hospitalized for aneurysm enlargement noted on ct to measure 6.5cm.The aneurysmal region started at the level of a previously implanted thoracic aortic stent and extended distally to the aortic bifurcation.The aneurysm involved the celiac axis, superior mesenteric artery and her single right side renal artery and underwent an additional endovascular procedure with additional stent placement.She was referred to mayo clinic for endovascular repair using a fenestrated branched stent graft.On (b)(6)2019, the patient underwent endovascular placement of a branched fenestrated device, for an extent type 2 thoracoabdominal aortic aneurysm using a patient specific directional branched stent graft.A proximal custom low-profile thoracic stent graft, 46mm x 32mm x 210mm component was placed with 3 directional branches.The celiac axis and superior mesenteric artery were both branched with gore® viabahn® vbx balloon expandable endoprostheses.The renal artery was branched with a both a gore® viabahn® endoprosthesis and an i-cast stent.The proximal and distal landing zones were ballooned and 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: 8366611
• Report Number: 2017233-2019-00100
• Device Sequence Number: 19299490
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 07/06/2018
• Device Catalogue Number: TGU454520
• Device Lot Number: 14194601
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/29/2019; 03/29/2019; 04/08/2019; 04/15/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 74