TriVascular Technologies, a maker of minimally invasive treatments for abdominal aortic aneurysms, said Thursday it is initiating a voluntary field safety corrective action for its 29 mm Ovation Prime aortic stent graft system due to a reported malfunction. The 29 mm version is one of five sizes offered by the company.
The Santa Rosa, Calif., company said fewer than 30 devices are subject to the corrective action and all are held by distributors outside the U.S. Any affected devices within its direct control have been pulled from distribution, TriVascular said.
The action stemmed from complaints that during the graft placement procedure, not all of the polymer fill went into or remained inside the graft, as intended. The system is supposed to deploy a set amount of polymer into the graft.
But in the case of the malfunctioning systems, some of the polymer may have remained in the polymer delivery kit or migrated outside the graft into the patient, TriVascular spokeswoman Shari O’Quinn told Device Daily Bulletin. The problem could lead to a drop in blood pressure, prolonged procedure time or failure to exclude the aneurysm, according to a letter that was sent to distributors.
Patients with existing Ovation Prime stent grafts don’t face any risk, the devicemaker said, adding that the complaint rate for the issue is only 0.3 percent. TriVascular said it has improved its manufacturing process and will continue to investigate reports and test inventory. — Kellen Owings
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