FDA – According to the U.S. Food and Drug Administration and MDDIonline.com report that Medtronic announced on February 23, 2021, the company is recalling unused Valiant Navion™ Thoracic Stent Graft Systems. According to Medtronic, three clinical trial patients sustained stent fractures. Two of the clinical trial patients have endured endoleaks, and another patient passed away.
During Medtronic’s global clinical trial of the thoracic stent graft system, a safety issue caused Medtronic to announce a global recall of new Valiant Navion thoracic stent graft systems. As a matter of patient safety, Medtronic has told surgeons to stop using the device until further notice immediately. Medtronic affirmed that three clinical trial patients in the Valiant Evo trial suffered stent fractures. Two of the three patients suffered type IIIb endoleaks, and of the patients died.
According to Medtronic, an independent imaging laboratory examined the available images from the clinical trial patients after the complications were discovered. Seven out of eighty-seven patients had stent ring enlargement beyond the medical device’s design specification. Those considerations will require an additional assessment to determine whether there is any clinical importance.
Medtronic is currently conducting a thorough technical investigation to ascertain the root cause of the stent ring enlargement and stent fracture issues. The analysis will require clinical follow-ups, additional imaging, and reviewing any commercial complaints.
Medtronic has contacted the U.S. Food and Drug Administration along with several other global regulatory agencies to share data concerning the issue. Patients with a Medtronic Valiant Navion thoracic stent graft system should consult their physician with any questions.
The recall process involves recalling all unused products, written recall alerts to physicians asking them to immediately stop using the Medtronic Valiant Navion thoracic stent graft systems, and providing instructions for returning the unused product to Medtronic.
Medtronic has prompted practitioners to review all available images of trial patients treated with the Valiant Navion thoracic stent graft system retrospectively, with particular attention to type IIIb endoleaks and stent fractures. If any imaging findings are discovered, physicians are asked to report the incidents to Medtronic and to the FDA. The manufacturer also urged doctors to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recommendations in the instructions for use for the device.
Clinical trial patients who have been implanted with the Medtronic Valiant Navion thoracic stent graft system should contact their physician for answers to their questions.
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