| TGA Action ID |
RC-2026-RN-00561-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
Catalogue Numbers: ATAA43120160A, ATAA43720160A
Supplied via Special Access Scheme (SAS) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
ATAA43120160A - 00733132659678, ATAA43720160A - 00733132659685 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following a request from the US FDA to update the Instructions for Use (IFU) for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) during its review of the TAMBE 2026 IDE Annual Report (G150071/R061) and PMA Annual Clinical Follow-Up Report (P230023/R006), Gore conducted an investigation into branch component occlusions.
Review of ongoing clinical follow-up data identified additional branch component occlusions beyond those reported at the time of approval and indicated that smaller renal artery diameters (=5 mm) may be associated with reduced renal branch patency in certain patients.
While no design or manufacturing deficiencies were identified, the IFU is being updated to provide additional information regarding branch component occlusions, associated clinical outcomes, long-term patency data, and anatomical factors that may influence branch performance |
| Instructions for Customers/Users |
Customers are to:
- Review the customer letter and enclosed Summary of IFU Changes, and ensure all relevant clinical and healthcare personnel are made aware of the updated information.
- Carefully assess the benefit-risk profile of treatment options in patients with anatomical characteristics associated with increased branch occlusion risk, including renal arteries =5 mm in diameter.
- Continue to monitor patients implanted with the device in accordance with the IFU and consider anatomical factors that may influence branch patency outcomes.
- Conduct regular imaging surveillance, including duplex ultrasound and/or CT Angiography (CTA), to facilitate early identification of branch narrowing or occlusion and enable timely clinical intervention where appropriate. |
| Action Commencement Date |
28/07/2026 |
| Responsible Entity |
|
| Contact Information |
0499 157 898 - Matt Rankin, W.L. Gore and Associates |