Event, implant dates: estimated date.The device was returned for analysis.The reported failure to advance could not be replicated in a testing environment as it was related to operational context 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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified lesion causing the reported failure to advance and subsequent handling damage noted during return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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