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

Model Number	TGT3420
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with a gore® tag® thoracic endoprosthesis.On (b)(6) 2022, follow-up imaging determined a distal type i endoleak, no aneurysm enlargement was reported.There is currently no treatment plan in place for the patient.
Additional Manufacturer Narrative
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular treatment for an thoracic dissectiion and was implanted with a gore® tag® thoracic endoprosthesis.On (b)(6) 2022, follow-up imaging determined a distal type i endoleak, no aneurysm enlargement was reported.On (b)(6) 2022, the patient underwent reintervention and a gore® tag® conformable thoracic stent graft was placed to extend coverage a couple centimeters above the celiac artery.This resolved the suspected leak.Not certain it was really a leak or just continuation of the dissection.The patient tolerated the procedure.
Additional Manufacturer Narrative
Images were provided to gore for evaluation and showed the following: one time point available for evaluation: post-implantation cta dated (b)(6) 2021.There appears to be dissection in the aorta from the head vessels to the sma.There appears to be a tear just distal to the implanted device in the descending thoracic aorta.Contrast appears in both lumens at the level of the tear.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: dissection, cad, hyperlipidemia, htn, traumatic brain injury, pneumonia due to covid, covid x 3, carotid stenosis, chronic kidney disease, thyroid disease, seizures, stroke.D11: patient medications include but are not limited to: baby aspirin, albuterol, lipitor, vitamin d3, guanadine, aerosoft, flovent, keppera, synthyroic, lisinoporil, lopressor, nephradapine, prednisone, zoloft, trazodone.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Common Device Name: 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13699635
• Report Number: 2017233-2022-02795
• Device Sequence Number: 5433964
• Product Code: MIH
• UDI-Device Identifier: 00733132613656
• UDI-Public: 00733132613656
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: TGT3420
• Device Catalogue Number: TGT3420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 02/28/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/24/2022; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 127 KG