(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: sion blue, guide cath: mach1 7f vl3.5, other: filtrap.Evaluation summary: a visual, dimensional and functional inspection was performed on the returned device.The reported shaft kink was able to be confirmed.The reported difficulty to position guide wire was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that due to a build-up of thrombus on the filter guide wire after thrombus aspiration was performed the 3.0 x 28 mm xience alpine met resistance with the guide wire resulting in the reported difficulty to position.Manipulation of the device resulted in the reported shaft kink and the noted multiple device damages.
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It was reported that the procedure was to treat an eccentric de novo lesion located in the mid left anterior descending coronary artery that was mildly tortuous, non-calcified and 90% stenosed.Due to a build-up of thrombus on the filter guide wire after thrombus aspiration was performed, the 3.0 x 28 mm xience alpine met resistance with the guide wire and was unable to advance any further so the device was removed from the anatomy.The mid-shaft was confirmed to be kinked.The device was replaced with a same size xience alpine to successfully complete the procedure.There were no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed an innermember separation.
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