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

Catalog Number TGU454515

Device Problems Difficult or Delayed Positioning (1157); Human-Device Interface Problem (2949)

Patient Problem Occlusion (1984)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The conformable gore® tag® thoracic endoprosthesis instructions for use (ifu) state ¿advance the endoprosthesis past the target location and pull back to desired position to release stored energy in the system¿.Per ifu, complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to improper endoprosthesis placement and branch vessel occlusion or obstruction.

Event Description

On (b)(6) 2018, the patient was implanted with two conformable gore® tag® thoracic endoprostheses as part of a thoracic endovascular aortic repair.During the procedure, the proximal endoprosthesis (tgu454515/17578537) was to be implanted at the distal ostium of the left common carotid artery (lcca).Upon deployment, the device partially and unintentionally covered the lcca.The physician believes the vessel coverage occurred because stored energy in the delivery catheter was not sufficiently removed by drawing the catheter back far enough prior to deployment.Although the lcca reportedly still had blood flow, the physician decided to implant a viabahn® balloon expandable stent in the lcca via antegrade approach.The patency of the vessel was preserved, and the procedure was concluded.The patient tolerated the procedure.

• Brand Name: CONFORMABLE 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: 7415609
• MDR Text Key: 105133433
• Report Number: 2017233-2018-00211
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2018

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: 11/27/2020
• Device Catalogue Number: TGU454515
• Device Lot Number: 17578537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR