It was reported that the patient presented with a st-elevation myocardial infarction (stemi).Pre-dilatation of the lesion was performed with a 2.5x12 mm traveler balloon dilatation catheter (bdc).After preparation of the lesion, the patient experienced ventricular tachycardia (vt) and it was stabilized within a few seconds.It was confirmed that the traveler bdc was not associated and there were no other issues with the bdc.The lesion was then stented with a 3.0x28 mm xience xpedition stent.Post procedure, the patient was transferred to the intensive care unit (icu) and was stable.After 3 hours the patient experienced vt and ventricular fibrillation (vf) and then cardiac arrest.Cpr was performed; however, the patient expired.There were no issues with the traveler bdc and there were no issues with deployment of the xience xpedition stent.No additional information was provided.
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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 death/expired, ventricular fibrillation and ventricular tachycardia are listed in the xience xpedition, everolimus eluting coronary stent systems instructions for use as a 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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