MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGMR404015J

Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2021 the patient underwent endovascular treatment of an arch aorta aneurysm using a gore® tag® conformable thoracic stent graft with active control system.On an unknown date in (b)(6) 2021, a follow-up imaging revealed a migration about 10mm distally and a proximal type i endoleak.The physician reported that the device probably migrated along the aneurysm after the initial procedure.On (b)(6) 2021, an additional stent graft was placed at the proximal side, the endoleak was resolved.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Code 213: a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Code 4581- this code is used to describe an endoleak.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to aortic expansion (e.G., aneurysm), endoleak, endoprosthesis migration and reoperation.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13042830
• MDR Text Key: 282489392
• Report Number: 2017233-2021-02622
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Catalogue Number: TGMR404015J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male