Three patients had broken stents and one patient died! Medtron recalls aortic graft stents

Coco Medtron has recalled its Valiant Navion chest stent transplant system worldwide, which is used to strengthen large blood vessels and make them potentially ruptured by aneurysms or other injuries.
February 17, Medtron, a medical technology company, announced that it had voluntarily recalled the unused Valiant Navion™thoracic stent transplant system globally and informed doctors to stop using the device immediately until further notice.
, Medtron has been in contact with the U.S. Food and Drug Administration (FDA) and other regulators around the world to share information on the issue.
said it would continue to work directly with regulators on the voluntary global recall.
a recent case observed by the medical technology giant, three patients were found to have broken stents and one died in a global clinical trial of Valiant Evo.
Valiant system is designed to strengthen weak aortas from the inside and reduce pressure on the walls of blood vessels.
device passes through the human artery through a minimally invasive catheter to avoid open surgery, and a synthetic fiber tube supported by a metal stent is deployed.
two of the three cases of broken stents have identified type IIIb leaks, which cause fibrous tubes to tear and blood to flow out of the implant's passages, according to Medtron.
these observations, an independent imaging laboratory reviewed all available images from patients in the Valiant Evo Global Clinical Trials.
further analysis of the images, it was found that in 7 out of 87 patients, the enlargement of the stent ring exceeded the implant's design specifications.
said the cases needed to be further evaluated to determine potential clinical outcomes and the company was conducting a comprehensive technical root cause investigation, including further review of subsequent clinical trial imaging and commercial complaints.
"Nothing is more important than the safety and well-being of patients, and we address product safety with the highest priority and urgency," Nina Goodheart, senior vice president of Medtron and president of cardiac vascular heart and aortic structures, said in a statement.
we have decided that this voluntary recall is necessary to ensure maximum patient safety.
as the investigation continues, we are committed to communicating with doctors and regulators in a timely manner.
" In addition, as part of the voluntary recall of unused products, Medtron sent a written letter to the physician recommending that the doctor review the available images of all patients treated with the Valiant Navion chest stent transplant system, with special attention to stent fractures and type IIIb leakage.
urged doctors to follow best clinical practice and conduct a follow-up assessment of patients at least once a year, in accordance with the imaging recommendations in the Valiant Navion Chest Stent Transplant System Instructions (IFU).
As usual, doctors are required to notify Medtron of any adverse events or product safety issues associated with the use of any Medtron products and should report them to the FDA's MedWatch Adverse Events Reporting Program.
outside the United States, adverse events or product safety issues related to the use of Medtron products should be reported to the relevant authorities.
source: 1. Medtronic recalls aortic graft implant after stent fractures, patient death2. Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System