The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the xience xpedition 48 everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a mildly calcified, non-tortuous left anterior descending artery.A 3.0x48mm xience xpedition stent was implanted on (b)(6) 2021.On (b)(6) 2021, the patient suffered from a subacute thrombosis and was connected to a machine for life support.The thrombosis was removed with aspiration and plain old balloon angioplasty.No additional information was provided.
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