(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 inadvertent deployment occurred.A 8.0-29 carotid wallstent was selected for use to treat the target lesion.However, during preparation, it was noted that the stent came off the catheter.The procedure was completed with another of the same device.No patient complications were reported.
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