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 effects of prolapse and occlusion are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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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Patient id: (b)(6).It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending (lad) artery.The 3.0 x 38 mm xience sierra stent delivery system was advanced and the stent was implanted.Post implant, angiography noted plaque prolapse and addition post dilatation was performed.The plaque prolapse was resolved with post dilatation.Post procedure, enzyme elevation was noted and was deemed related to occlusion of a small diagonal branch.The patient remained asymptomatic and no intervention was performed.The event resolved three days post procedure.No additional information was provided.
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