- Medtronic on Wednesday announced a voluntary global recall of its Valiant Navion thoracic stent graft system after a patient death was reported in a clinical trial.
- The medtech giant has informed physicians to immediately cease use until further notice. In addition to the single fatality, three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, two of which were Type IIIb endoleaks, an uncommon but serious late complication of endovascular aortic aneurysm repair.
- FDA in October 2018 approved Medtronic's Valiant Navion system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms. The Valiant Evo prospective, nonrandomized, single-arm trial is seeking to demonstrate the safety and efficacy of the stent graft system in patients with a descending thoracic aortic aneurysm who are candidates for endovascular repair.
Thoracic aortic aneurysms are rare, occurring in approximately 6-10 per every 100,000 people, and treatment may include minimally invasive surgical techniques such as stenting, according to the Society for Vascular Surgery. Medtronic's Valiant system is designed to treat descending thoracic aortic aneurysms using a minimally invasive procedure called endovascular stent grafting, which reinforces the wall of the thoracic aorta to prevent the aneurysm from rupturing.
The company said an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial, which found that seven 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 said in a statement, adding that it is now conducting a "comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging."
Medtronic has also advised physicians globally to retrospectively review all available images of patients treated with the system with "specific attention to stent fractures and type IIIb endoleaks" and to contact the company if any such imaging findings are observed and to report any issues to the FDA's MedWatch Adverse Event Reporting program.
The medtech giant said it has contacted FDA and regulatory agencies in other countries to share information related to the potential patient safety issue. In addition to the FDA's approval, the Valiant Navion system received CE Mark in November 2018 and was approved by the Ministry of Health, Labour and Welfare in Japan in September 2019.
Medtronic in July 2020 announced the start of a prospective, observational, global, multi-center, real-world, post-market study to evaluate the safety and effectiveness of Valiant Navion. The DISSECT-N study's goal is to enroll at least 200 patients across approximately 45 sites in North America, Europe, and Asia Pacific.