The device was not returned for evaluation.This complaint was raised in response to the review of a journal article, which does not include information relating to the product type or the lot number.Therefore, a review of the device history record could not be performed.The ifu for fenestrated endovascular devices lists renal complications as a potential adverse event, and states: "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft." based on the provided information it is not possible to determine a definite root cause.
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