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

Catalog Number TGU373720J

Device Problems Difficult to Remove (1528); Material Separation (1562); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent an endovascular procedure using the conformable gore® tag® thoracic endoprosthesis to treat a thoracic aortic aneurysm.It was reported that as the patient's femoral or iliac artery was not appropriate as an access due to the abdominal aorta replacement with a y graft, an initial plan for the procedure had been to access the device from the ascending aorta after the total debranching surgery to the brachiocephalic, the left common carotid, and the left subclavian artery.However, this plan was changed per the physician's request to the left femoral access with the debranching surgery to the left common carotid and the left subclavian artery, intentionally covering these arteries with the device.It was reported that the gore® dryseal sheath with hydrophilic coating was stuck at a tortuous leg of the y graft and could not be advanced, and that the device was then advanced outside the sheath to the intended position without any remarkable resistance noted.As planned the device was slowly deployed and intentionally and slightly covered the brachiocephalic artery.During removal of the delivery catheter of the device after the deployment, the leading olive was reportedly caught at the tortuous leg of the y graft at the level of common iliac artery.It was reported that as the physician forcibly removed the delivery catheter leading end including the leading olive and the 1-2cm of the polyimide was separated and remained in the patient.The physician made multiple attempts to remove the leading end with a snare catheter without success as the leading end was completely stuck at the tortuous leg and could not be moved.The physician then decided to convert the procedure to an unplanned aorto-uni-iliac (aui) with femoral-femoral bypass procedure.The gore® excluder® aaa endoprosthesis iliac extender component was implanted and covered the left leg.The blood flow to the left lower extremity was confirmed and the procedure was completed.The patient tolerated the procedure.The physician admitted that the delivery catheter should not have been forcibly removed and commented that the cause of the separation was the access from the left femoral artery, which was not appropriate.The physician also commented that there should be no issue with the leading end remaining in the patient as the area where it remains will be thrombosed in the near future and it will not move distally from the area.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The delivery catheter was forcibly removed as its leading olive was stuck at the tortuous leg of the y graft.The cause of the separation was reportedly the access from the left femoral artery, which was not appropriate.

• 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: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3831704
• MDR Text Key: 4405513
• Report Number: 2017233-2014-00275
• 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: 05/07/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: TGU373720J
• Device Lot Number: 12405980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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: DSL2228J/12048285, PXL161007J/12173925
• Patient Outcome(s): Other
• Patient Age: 81 YR