(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual inspections was performed on the returned device.The deployment difficulty was not confirmed as the stent was not returned and the returned condition of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot or relabeled lot.The investigation was unable to determine a conclusive cause for the reported deployment issue and physical resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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