It was reported that during unpacking of the 3.0 x 18 mm xience alpine stent delivery system (sds) , the stent was noted to be defective.Therefore, the sds was not used.There was no patient involvement.A new 3.0 x 18 mm xience alpine sds was used to the complete the procedure.There was no clinically significant delay in the procedure.Return device analysis found a leak coming out from the crack on the hub.No additional information was provided.
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The device was returned for analysis.The reported product quality problem was confirmed through the identification of a cracked hub.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported product quality problem.A cracked hub was identified during return device analysis confirming the reported defective device.Factors that may contribute to hub breaks include, but are not limited to, material damage, mishandling by user, and interaction between the hub and other device (stopcock, indeflator, etc.).Additionally, it should be noted that the sidearm of the device is inspected at multiple stations during manufacturing and no issue was identified at any stage.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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