FDA MedWatch - Unused Valiant Navion Thoracic Stent Graft System by Medtronic: Recall - Due to endoleaks, stent fractures and stent ring enlargement

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Unused Valiant Navion Thoracic Stent Graft System by Medtronic: Recall - Due to endoleaks, stent fractures and stent ring enlargement AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology ISSUE: Medtronic plc issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported. Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. Upon further analysis of the images, seven (7) out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance. Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging. For more information about this recall, click on the red button "Read Recall" below. RECOMMENDATIONS:  Patients with a Medtronic Valiant Navion thoracic stent graft system should consult their physician with any questions. As part of the voluntary recall of unused product, physicians were sent written communication from Medtronic directing them to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system and instructions for returning unused product to Medtronic. Medtronic advises physicians to retrospectively review all available images of patients treated with Valiant Navion thoracic stent graft system with specific attention to stent fractures and type IIIb endoleaks and contact Medtronic if any imaging findings are observed. Medtronic urges physicians to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recommendations in the Medtronic Valiant Navion thoracic stent graft system Instructions for Use (IFU). Physicians are asked to notify Medtronic of any adverse events or product safety issues associated with use of any Medtronic product, which also should be reported to the FDA's MedWatch Adverse Event Reporting program.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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