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

Catalog Number TG3420

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 06/23/2014

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to aneurysm enlargement.(b)(4).

Event Description

On (b)(6) 2009, the patient underwent a first-staged procedure using a gore® tag® thoracic endoprosthesis (tg3420/06650151) to treat a thoraco-abdominal aortic aneurysm which had extended from the descending thoracic aorta to the abdominal aorta.The abdominal aorta was surgically replaced with a vascular graft, followed by two other surgical grafts being prepared on the abdominal vascular graft: one was for a bypass to the celiac, superior mesenteric and bilateral renal arteries to maintain blood flow to the abdominal branch vessels, while the other was for a conduit access for the endoprosthesis.The endoprosthesis was advanced through the conduit and successfully deployed distal to the left subclavian artery, and the patient tolerated the first-staged procedure.On (b)(6) 2009, the patient underwent the second-staged procedure.Two gore® tag® thoracic endoprostheses (tg3420/06690592 and tg3115/06751609) were deployed from the distal portion of the initially implanted endoprosthesis to just above the abdominal vascular graft.The patient tolerated the procedure without endoleaks present.On (b)(6) 2009, the patient was discharged of the hospital.Aneurysm diameter was 46mm without endoleaks revealed.On (b)(6) 2010, in six-month follow-up study, aneurysm diameter was 45mm.On (b)(6) 2010, in one-year follow-up study, aneurysm diameter was 45mm.On (b)(6) 2012, in three-year follow-up study, aneurysm diameter was 45mm.On (b)(6) 2013, in four-year follow-up study, aneurysm diameter was 44mm.On (b)(6) 2014, in five-year follow-up study, aneurysm diameter had increased to 63mm.Endoleaks were not revealed.Later, the patient completed the five-year follow-up studies.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7111913
• MDR Text Key: 94632098
• Report Number: 2017233-2017-00645
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: TG3420
• Device Lot Number: 06650151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TG3420/06690592 AND TG3115/06751609
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Weight: 59