(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effects of cardiac arrest, hypotension, respiratory distress, and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems electronic instructions for use 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 the design, manufacture, or labeling of the device.The other xience sierra device is being filed under a separate medwatch mfr number.
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It was reported that the procedure was to treat a circumflex artery.Two xience sierra stents (2.25x38 and 3.25x23) were successfully implanted at the lesion.There were no device issues and the stents were well-apposed to the vessel wall.While finishing the case, the patient stated they didn't feel right and there was a drop in blood pressure.A thrombus was observed in both stents and a thrombectomy was performed.The patient then stopped breathing and experienced cardiopulmonary arrest.Cardiopulmonary resuscitation was performed, the patient was intubated, medications provided, and a balloon pump (iabp) was placed to stabilize the patient.The patient was taken to critical care for observation.The event required prolonged hospitalization.There was no adverse patient sequela reported.No additional information was provided.
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