Device is a combination product.Method: labeling evaluation.The device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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It was reported via facility medwatch # 5077592 that stent thrombosis occurred.In (b)(6) 2017, the patient presented to emergency room (er) with st-elevation myocardial infarction (stemi) and was then admitted.The patient was sent to cardiac catheterization lab which revealed total occlusion in the mid right coronary artery (rca) with large amount of thrombus.Overlapping inflations was then performed using 2.5x15 emerge balloon catheter providing sluggish flow.Thrombectomy was performed and brisk flow returned with minimal residual defect.Subsequently, a 3.5x28mm synergy stent was deployed in the rca with good results.The procedure was completed with no patient complications.The patient did well and was discharged on acetylsalicylic acid (asa) and brilinta.In (b)(6) 2018, the patient experienced chest pain and called emergency medical services (ems).Patient takes asa and brilinta before arriving in the er with stemi.Cardiac catheterization revealed total thrombotic occlusion of the previously placed stent in the mid rca which was then treated with thrombectomy and 3.5x20 nc emerge balloon.Timi iii flow was achieved and the procedure was completed.The patient did well and was discharged on asa and prasugrel.
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