The device was returned for analysis.The reported material split, cut or torn was able to be confirmed.The reported difficult to advance/position and the reported failure to deploy the stent were 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 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 interaction as the tight lesion was compressing the sheath resulted in the reported difficult to advance/position and the reported activation failure.Interaction and/or manipulation of the device resulted in the reported material split, cut or torn/noted sheath separation and the noted wrinkled sheath.The noted multiple bends on the jacket likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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