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

Model Number	TAC083715A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: during a tbe (thoracic branched endoprosthesis) aaa (arch aortic angiogram) the surgeon was inserting the stent through sheath and aorta.When trying to maneuver the stent around the bend of the aorta the stent/device bent and was unable to be used.Therefore, the device was removed from the patient and not deployed.No harm was seen or done to the patient.New device was opened and inserted.From operative note: the lunderquist was advanced through the main body of the graft.The graft was advanced over the wires.It did not easily advanced through the uncovered portion of the stent graft.There appeared to be some wire wrap which was resolved by removing the graft from the patient.Again we attempted to advance the graft but it would not advance through this region smoothly.

• Brand Name: GORE TAG THORACIC BRANCH ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 22148693
• Report Number: 22148693
• Device Sequence Number: 18050982
• Product Code: MIH
• UDI-Device Identifier: 00733132654116
• UDI-Public: (01)00733132654116
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TAC083715A
• Device Catalogue Number: TAC083715A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 05/23/2025