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

Model Number	TGU282815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, hematoma.
Event or Problem Description
On (b)(6) 2021 the patient underwent part one of a staged procedure to treat a thoracoabdominal aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis (ctag) in the gore® excluder® (b)(6) clinical trial.On (b)(6) 2022 a retroperitoneal hematoma was observed.It was reported that the hematoma was study procedure related.On (b)(6) 2022 hematoma evacuation was performed.There were no further reported issues.The patient tolerated the procedure and it was reported that computed tomography imaging will be performed to evaluate the placement of the ctag device prior to completing the (b)(6) phase of the staged procedure.

• Brand Name: CONFORMABLE 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13300431
• Report Number: 2017233-2022-02676
• Device Sequence Number: 4964495
• Product Code: MIH
• UDI-Device Identifier: 00733132618057
• UDI-Public: 00733132618057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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: 03/06/2024
• Device Model Number: TGU282815
• Device Catalogue Number: TGU282815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/19/2022
• Date Device Manufactured: 03/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BABY ASPIRIN, ATORVASTATIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White