Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of turbohawk and silverhawk peripheral plaque excision systems.Survey results received for an interventional cardiologist with 24 years¿ experience who was been using both the silverhawk and turbohawk directional atherectomy systems since 2017.The physician has used a total of 70 silverhawk peripheral plaque excision systems with 40 of these being used in the past 12 months.The physician reported the device related complications of arterial dissection, arterial spasm, and embolism or arterial thrombosis during use of the device.None of these events were reported previously to medtronic.The physician considered arterial dissection and arterial spasm events to be no at all concerning.The physician has commented that dissection is a complication provided by the technique of atherectomy and is easily treatable with stent implantation.Similarly, for spasm events the physician has reported it a complication provided by the technique of atherectomy and is easily treatable with administration of vasodilators.The embolism or arterial thrombosis event was reported to be somewhat concerning, and the physician has provided feedback that treatment is generally pharmacological and resolving.
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