Clinical evaluations was unable to find substantial evidence to support the following reported events; off label procedure, aortic stenosis, secondary endovascular procedure, and favorable patient disposition.The most likely cause of the inadequate stent graft patency is the reported off-label use (aortic stenosis and stent buckling).Procedure related harms and the final patient disposition could not be ascertained due to the lack of medical information surrounding the implant or the repair procedure.Reportedly, the patient is doing well; there have been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: udi#, device code: remove 3323, 3263.
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