[Image courtesy of Medtronic]
The voluntary recall announcement, posted today on the website of Germany’s Federal Institute for Drugs and Medical Devices ( BfArM ), tells health providers to identify and return the Endurant and Endurant II stents covered in the recall that are still in inventory. Since potential problems take place during implanting, the recall doesn’t cover stents already implanted inside people.
“Patients who have been implanted with an EndurantEndurant II 23mm or 25mm bifurcated stent graft system affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with standard practice,” Medtronic spokesperson Krystin Hayward said when contacted by MDO.
And FDA spokesperson said the agency was in communication with Medtronic about the recall but did not presently have additional information to share.
Medtronic in the letter says it received 20 complaints between May 2015 and January 2017 of health providers taking additional interventions during procedures because they mistakenly thought a patient had an acute Type III Fabric endoleak. There have been two cases of adverse events. One person died three weeks after the implantation procedure, though it was inconclusive whether the secondary procedure caused the death.
The potential flaw in the stent graft systems involves a permeability variation that could cause a doctor to mistakenly categorize a Type IV endoleak, which self-resolves over time, as an acute Type III Fabric endoleak.
The recall is limited to a subset of 23 mm and 25 mm Endurant and Endurant II stent grafts that were manufactured with specific lots of graft material, Medtronic said. The subset includes 3,331 units globally, though many are already implanted inside people, according to Hayward. A full list of serial numbers is included in the voluntary recall announcement.
The full extent of the recall was not immediately clear. FDA’s MAUDE database includes dozens of reports about Endurant and Endurant II bifurcated stent grafts for 2017 alone, though a recall did not appear to be listed on FDA’s website.
The Endurant II stent graft system is meant to treat abdominal aortic aneurysm. Placed inside the abdominal aorta through a catheter-based procedure, it is designed to conform to a broad range of aortic anatomies, according to Medtronic.
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