(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.(b)(4).
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It was reported that the procedure was to treat a moderately calcified distal left anterior descending (lad) artery.An unspecified stent was placed in the mid to proximal lad.A 2.5 x 15 mm alpine stent delivery system was being advanced through the previously placed stent to the distal lad; however, the stent could not be seen on the balloon.The guiding catheter was cut open to see if the stent had come off in the guiding catheter, but it was not there.The device was not examined before prep or entering the anatomy so it could not be confirmed the stent was on the balloon when advancing.Angiography was used to search the anatomy but the stent could not be found in the anatomy.It cannot be confirmed that the lab and packing were searched.There was no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).The device was not returned for analysis.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 similar incidents from this lot.The xience alpine everolimus eluting coronary stent system electronic instructions for use states: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.The reported violation of the ifu does not appear to have caused or contributed to the stent dislodgement.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.The foreign body in the patient appears to be related to circumstances of the procedure as the stent was unable to be located therefore it is possible it remains in the patient anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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