(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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(b)(4).Evaluation summary: unique device identifier (udi): (b)(4).The device was returned for analysis.The damaged and loose stent were able to be confirmed.The difficulty removing the device and protective sheath could not be replicated in a testing environment due to the condition of the returned device.Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties removing the device and the protective sheath however the loose and damaged stent appear to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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