Pma/510(k) # k162717 device evaluation the evo-20-25-12.5-e device of lot number c1875361 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Several attempts were made to obtain additional information regarding this device.However, no response has been received to date.If it is returned in the future then the file will be updated accordingly.Document review including ifu review: prior to distribution evo-20-25-12.5-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-12.5-e of lot number c1875361 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1875361.It should be noted that the instructions for use (ifu0061) states the following: "visually inspect with particular attention to kinks, bends and breaks.If 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 from the available information.Due to the limited information available it was agreed with engineering that assigning the most common inability to deploy failure mode section would be the most appropriate approach in this case.Typically the most common possible root cause attributed to inability to deploy has been tortuous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure and resulting in deployment difficulties.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary the complaint is confirmed based on customer testimony.It is unknown whether the patient experienced any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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