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 balloon profile problem and stent deployment issue occurred.The target lesion was located in the ostial right coronary artery (rca).A 3.50 x 8 synergy ii drug eluting stent was advanced to treat the lesion.However, when the physician inflated the stent delivery balloon, the balloon did not inflate uniformly.The proximal portion inflated first which caused the whole system to "watermelon seed" back and caused the stent to protrude into the aorta.The procedure was completed with this device.No patient complications were reported and patient's status was ok.
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