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

Catalog Number	ATAA43720160A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the patient underwent an endovascular procedure to treat a thoracoabdominal aortic aneurysm utilizing a gore® excluder® thoracoabdominal branch endoprosthesis (tambe).Reportedly, as soon as the tambe device was introduced into the 22fr dryseal sheath, blood started leaking out of the seam on the white deployment handle near where the white handle is attached to the blue catheter.Blood was not leaking out of the tuohy borst valve.The cause of the blood leaking is unknown, and it was reported that nothing appeared to be broken or loose.Blood was leaking out of the deployment handle for the duration of the tambe portion of the procedure, which was about 2 hours.It was reported the procedure was not hurried by the physician, nor was it prolonged due to the bleeding.The patient required a blood transfusion.Total blood loss amount is unknown.There were no other tambe or sheath issues reported.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code c20 -the device was discarded at the treating facility and was therefore not available for direct engineering evaluation by gore.H6: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® EXCLUDER® THORACOABDOMINAL BRANCH 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: brianna zipprich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24259882
• Report Number: 2017233-2026-07110
• Device Sequence Number: 9550110
• Product Code: MIH
• UDI-Device Identifier: 00733132659685
• UDI-Public: (01)00733132659685(17)280727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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 Catalogue Number: ATAA43720160A
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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
• Patient Age: 81 YR
• Patient Sex: Unknown
• Patient Weight: 76 KG