Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.
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It was reported through the results of a clinical trial, that the subject had an adverse event of vessel spasm post pta procedure and recovered.Approximately one year post index procedure, the subject had an 90 % target lesion restenosis.A standard pta catheter was used to successfully treat the restenosis.The current status of the subject was not provided.
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