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Medtronic issues urgent field safety notice for stent graft systems

Posted: 16/03/2017

Medical device company Medtronic has issued a voluntary recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems which has greater susceptibility to fabric permeability variations that may be associated with endoleaks. The recall only affects specific models and serial numbers.

Although the risk of problems is thought to be low, there remains potential for unnecessary secondary interventions to treat endoleaks if they arise.

Elise Bevan, an associate in the product liability team at Penningtons Manches LLP, said: “We understand that Medtronic received 20 complaints between May 2015 and January 2017 relating to this issue. Additional interventions were required at the time of the procedures. There are also reports that one patient died three weeks after surgery, but the cause of death is inconclusive.

“Currently, there are no actions required for patients already implanted as the potential problem arises at the point of implantation rather than subsequently.  Therefore, the advice is that patients who have been implanted with a stent draft system affected by this recall do not require any additional follow-up but should be monitored in accordance with standard practice.”

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