Device is a combination product.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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Same case as: 2134265-2017-01776 and 2134265-2017-01777.It was reported that the patient experienced thrombosis, chest pain, st elevations and expired.The patient presented with a st elevated myocardial infarction.The target lesion was located in the (b)(6) stenosed, mildly tortuous and mild to moderately calcified right coronary artery (rca).Three synergy ii stents were implanted overlapping in the rca; a 3.00 x 38 in the proximal to mid rca, another 3.00 x 38 in the mid rca, and a 3.50 x 12 in the distal rca.The procedure was completed and heparin bivalirudin, and clopidogrel blood thinning medication was administered.The patient was in recovery for 2-3 hours when chest pain and st elevations occurred.The patient was transferred back to the cardiac cath lab for treatment.The following day all 3 stents had complete thrombosis and angiojet thrombectomy was performed, however the patient expired.
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