It was reported that the procedure was to treat a totally occluded proximal right coronary artery that was 100% stenosed.Prior to the initial procedure, the patient was experiencing chest pain, which was diagnosed as st-elevation myocardial infarction (stemi).Medication was provided.Aspiration was performed repeatedly, and a lot of thrombosis was noted.Intravascular ultrasound (ivus) was performed and diffuse plaque was confirmed.A 3.50 x 38mm xience sierra stent was deployed with 20 atmospheres, three times for 20 seconds.Afterwards, a no-flow occurred and additional dilatation was done.Also, creatine kinase had elevated to 2000 and medication was provided.Re-flow was restored.Ivus confirmed there was no stent malapposition.The procedure was completed successfully.Some time later on the same day, the patient experienced st-elevation while in cardiac/coronary care unit (intensive care unit) and revascularization was performed with administration of medication.In-stent thrombosis was then noted, and dilatation was performed with a non-abbott device, and re-flow was restored.The patient received an intra-aortic balloon pump (iabp) as treatment.The patient recovered.Per the physician, the event and the device are not related.No additional information was provided.
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Subsequent to the initially filed mdr report, slow flow was already noted before implanting the xience sierra.Additionally, the xience sierra was deployed at 20 atmospheres by a 3.5mm balloon dilatation catheter.The procedure was to treat a de novo lesion in the rca.No additional information was provided.
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(b)(4).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 occlusion and thrombosis are listed in the instructions for use xience sierra everolimus eluting coronary stent systems as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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