The device was returned for analysis.The reported difficulty to advance could not be confirmed due to the condition the device was received for analysis.All noted device damage and stent movement is likely due to handling and/or manipulation of the device during the difficult advancement.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 difficulty to advance; however, factors that could contribute to difficult to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, product placement technique, product size selection and accessory product support.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a de novo lesion in the first obtuse marginal branch that was 90% stenosed.A 2.5 x 15 mm xience alpine stent delivery system was used; however, it met resistance with an unspecified guide wire that was already in the anatomy.Therefore, another 2.5 x 15 mm xience alpine stent was implanted to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that the stent implant appears to have moved proximally, approximately 1mm from the original crimp marks on the balloon markers.No additional information was provided.
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