(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Use after expiration.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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(b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.It should be noted that the rx acculink carotid stent system electronic instruction for use states: do not use after the, use, by date specified on the package.It should be noted that the rx acculink carotid stent system electronic instruction for use (ifu) states: do not use after the use by date specified on the package.The investigation determined the reported difficulty appears to be related to an ifu deviation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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