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

Catalog Number TGT2610

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Renal Failure (2041); Test Result (2695)

Event Date 04/01/2010

Event Type  Injury  

Event Description

On (b)(6) 2010, the patient underwent endovascular repair of a thoracic aortic aneurysm using two gore® tag® thoracic endoprostheses (tgt2610/7460930 and tgt2815/7583174).A conduit was built in the left common femoral artery, and two stent grafts were advanced from the conduit and deployed.It was revealed that the renal arteries were embolized during the procedure, causing renal insufficiency.Pre-procedure creatinine was measured to be 2.02 mg/dl.Diuretics were administered to treat the renal insufficiency, and the procedure was concluded.On (b)(6) 2010, the patient was discharged of the hospital.The embolism of renal arteries and the renal insufficiency had persisted with pre-discharge creatinine measured to be 2.82 mg/dl.Aneurysm diameter was 58mm.Later in three more follow-up studies performed, the embolism of renal arteries and the renal insufficiency had still persisted, but the patient was monitored.Aneurysm diameter had shrunk to 41mm.On (b)(6) 2013, in three-year follow-up study, it was revealed that the embolism of renal arteries had been resolved.Aneurysm diameter was 38mm.On (b)(6) 2014, in four-year follow-up study, aneurysm diameter was 33mm.The renal insufficiency had still persisted, but a wait-and-watch approach had been continued.It was reported that prior to the initial procedure, circumferential thrombus had been present in the thoracic and abdominal aorta.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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 86001
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4886969
• MDR Text Key: 6262311
• Report Number: 2017233-2015-00395
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: TGT2610
• Device Lot Number: 7460930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 58