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

Catalog Number TGU404015J

Device Problems Premature Activation (1484); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the safety and effectiveness of the gore® tag® thoracic endoprosthesis have not been evaluated in patients with previous stent graft or previous surgical repair in the descending thoracic aortic area.

Event Description

On an unknown date, the patient was implanted with an open stent graft in the descending thoracic aorta, and a zenith abdominal stent graft below the renal artery.On (b)(6) 2016, the patient underwent an endovascular procedure using a conformable gore® tag® thoracic endoprosthesis (tgu404015j/14634389) to repair a thoracic aortic aneurysm which was located just below the distal edge of the open stent graft.A 24 fr introducer sheath was inserted up to the level of the zenith abdominal stent graft.There was no reported resistance felt while advancing the tag® device through the zenith stent graft; however, the tag® device reportedly could not be advanced to the target because there was a 50 degree curve in the descending thoracic aorta distal to the target.It was reported the tag® device unintentionally deployed distal to the targeted landing zone without the physician's operation.According to the report, the deployed device landed in the descending thoracic aorta, and no major branch vessels were covered.The physician was reportedly able to implant an additional conformable gore® tag® thoracic endoprosthesis using a pull-through guide wire.The patient tolerated the procedure.

• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5507765
• MDR Text Key: 40844343
• Report Number: 2017233-2016-00250
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2018
• Device Catalogue Number: TGU404015J
• Device Lot Number: 14634389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• 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 Age: 78 YR