Pma/510(k) #: k163468.Device evaluation: 1 unit of evo-22-27-12-d lot# cf1720059 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.An image was provided with the complaint which looks like there is polyimide damage just below the white introducer tip.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 29 oct 2021.On evaluation of the device the polyimide was observed to be kinked.Safety trigger was returned separately.Actuation of handle was possible for deployment and recapture.Stent deployed without any issues.Lock wire was removed.Document review: prior to distribution evo-22-27-12-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-12-d of lot number cf1720059 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has or has not previously occurred with the current lot number.Based on the information available to date, there is or there is no evidence to suggest that there are any manufacturing issues associated with lot number cf1720059.It should be noted that the instructions for use (ifu0053) states the following: ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use"¿.There is not sufficient evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to transportation, storage facilities or handling of the device during removal from packaging.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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