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

Catalog Number TGU343420

Device Problem Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 06/14/2017

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.(b)(4).Per the gore® tag® thoracic endoprosthesis instructions for use, 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) 2017, a conformable gore tag thoracic endoprosthesis (tgu343420/16093571) was implanted to treat a type b aortic dissection.During the procedure, the device reportedly moved proximally of its intended landing site during deployment (distance unknown), unintentionally covering the left common carotid artery (lcca).The physician performed a cut-down on the lcca and placed a carotid stent to preserve blood flow.The procedure was completed without any further reported complications, and 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: 6687162
• MDR Text Key: 79072161
• Report Number: 2017233-2017-00332
• 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: 06/14/2017

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: 02/14/2020
• Device Catalogue Number: TGU343420
• Device Lot Number: 16093571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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): Other; Required Intervention
• Patient Age: 58 YR