Reportable based on device analysis completed on 04-feb-2021.It was reported via voluntary medwatch/maude report #: (b)(4) that guidewire loading difficulty and tip damage occurred.Post transcatheter aortic valve replacement, the patient presented to the emergency department with chest pain and non-st elevation myocardial infarction.When a 3.00 x 28mm synergy ii drug-eluting stent was opened, tip was damaged and unable to load into the wire.The procedure was completed with another of the same device and no patient complications were reported.However, returned device analysis revealed stent damage.
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