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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It was reported that product sterility was compromised.A 3.00x16mm promus premier¿ drug-eluting stent was selected for use.However, while trying to open the package, the product was contaminated.The procedure was completed with another of the same device.No patient complications were reported.
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