The device was not returned 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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to the calcification of the lesion the stent could not open the narrow blood vessel; thus resulting in the reported patient-device incompatibility.The treatment appears to be related to the operational context of the procedure as the patient was transferred to surgery for carotid endarterectomy.The stent was stripped out.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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The device was returned for analysis.The reported patient-device incompatibility recoil was unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to the calcification of the lesion the stent could not open the narrow blood vessel; thus resulting in the reported patient-device incompatibility.The treatment appears to be related to the operational context of the procedure as the patient was transferred to surgery for carotid endarterectomy.The stent was stripped out.The noted device damages (bent and kinked stabilizer, bent shaft, separated guidewire lumen) likely occurred due to inadvertent mishandling and/or during shipment for return analysis.A follow up confirmed no part of the device remains in the anatomy and was discarded.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.
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