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

Catalog Number TGT2815

Device Problems Degraded (1153); Material Rupture (1546)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 04/21/2010

Event Type  Injury  

Event Description

On (b)(6) 2010, the patient underwent an open abdominal surgery to place a bypass from the abdominal aorta to the abdominal aortic branches (superior mesenteric artery and left renal artery) which would be covered by a gore® tag® thoracic endoprosthesis in the following procedure.It was reported that a saphenous vein graft (svg)was used for the bypass of sma.On (b)(6) 2010, the patient underwent endovascular repair of a thoraco abdominal aortic aneurysm using a gore® tag® thoracic endoprosthesis and a non-gore manufactured stent graft.On unknown date, the patient presented with the ruptured svg used to bypass the sma and the device infection.The patient underwent retroperitoneal drainage, surgical hemostasis of the ruptured svg, antibiotic medication, and dialysis.On (b)(6) 2010, the patient expired due to infection.It was reported that the physician believes the infection was due to the surgical bypass performed on the abdominal aortic branches prior to the implantation of the devices.It was also reported that the rupture of the svg was due to the deterioration of the svg due to infection.

Manufacturer Narrative

A review of the manufacturing and sterilization paperwork for the devices verified that the lots met all pre-release specifications.Per 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 infection and death.

Manufacturer Narrative

Corrected the implant date.

• 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: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4120332
• MDR Text Key: 20322070
• Report Number: 2017233-2014-00503
• 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,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: TGT2815
• Device Lot Number: 7583167
• 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: 03/08/2010
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 68