Device is a combination product.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 thrombosis occurred.A synergy¿ drug-eluting stent was implanted in the proximal left anterior descending (lad).However, 12 hours post procedure, the patient came back to the catheterization laboratory with stent thrombosis.No further patient complications were reported and the patient's status was fine.
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