GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

On 09/23/2020, the firm sent an "URGENT Medical Device Safety Correction" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter inability to complete secondary deployment and that the Recalling Firm will be updating it Instruction for Use to include a new Warning: Secondary deployment events have occurred where the device does not open to full diameter after Secondary Deployment Handle actuation, and the deployment line is not accessible via the Deployment Line Access Hatch. If this event occurs, Gore recommends using the GORE Tri-Lobe Balloon Catheter to expand the device from trailing end to leading end after complete delivery system component removal. (Please refer to the GORE Tri-Lobe Balloon Catheter Instructions for Use for pertinent recommended volume, directions and warnings.) Ballooning of a non-fully expanded stent graft may lead to improper placement of the stent graft and/or branch vessel occlusion or obstruction. Use of an occlusion balloon may lead to device distal displacement during deployment (windsock effect) and has been observed to lead to branch vessel occlusion or obstruction. Customers are instructed to: -Take note of amendment/reinforcement of Instructions For Use (IFU) - Please respond to the enclosed acknowledgement - Please share this letter with others in your hospital or clinic as appropriate The Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and is not removing the affected products from the market. There are no actions required for patients already implanted with the Thoracic Stent Graft. Please contact the Recalling Firm's Customer Service (email: [email protected] or by phone at 800-528-8763) with any questions related to this