Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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It was reported that stent dislodgement occurred.The target lesion was located in a very calcified vessel.A 2.25x20 synergy ii drug-eluting stent was able to cross the lesion.However, during an attempt to initially deploy the stent, it was noted that the stent came off the balloon.The dislodged stent was crushed into the vessel wall and the procedure was completed with a different device.No patient complications were reported.
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