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

Device Problem Disconnection (1171)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

As gore was unable to determine which 34 mm gore® tag® device was involved in the suspected type iiia endoleak, both devices will be included in this report.Item and lot/serial numbers for the devices were requested by gore but were not available.Used to capture endoleak.The device was discarded at the facility and, therefore, was not available for direct analysis by gore.A review of the manufacturing records for the devices could not be performed as item and lot/serial numbers were not available.It should be noted the gore® tag® thoracic endoprosthesis instructions for use (ifu) state ¿complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, endoleak and reoperation.¿.

Event Description

On an unknown date around 2013, the patient underwent endovascular treatment of a thoracic aortic aneurysm using two gore® tag® thoracic endoprostheses.An axillary-axillary artery bypass was also performed.It was reported a 34 mm gore® tag® device was implanted proximally, then a second 34 mm gore® tag® device was implanted distally.On an unknown date, follow up magnetic resonance imaging (mri) reportedly revealed a possible type ii or type iii endoleak contributing to aneurysm enlargement.Due to the patient's allergy to contrast, no computed tomographic angiography was performed.On (b)(6) 2021, a reintervention procedure was performed whereby two additional stent grafts were placed to reline the existing stent graft system.The patient tolerated the procedure.Due to the patient's contrast allergy, no final angiography was performed.An mri will be performed at the next follow-up examination.The physician stated if a remaining endoleak is revealed on the upcoming mri, then he will rule out type iii and consider the issue a type ii endoleak.

Manufacturer Narrative

Added g3/g4, h1/h2 and h6: investigation conclusion.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12961565
• MDR Text Key: 284537881
• Report Number: 2017233-2021-02600
• 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: 06/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male