(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that during preparation and before use, when the xience alpine 2.5 x 12 mm stent delivery system (sds) was unpacked, it was found that the proximal edge of the stent was located at the proximal side of the proximal marker.As the stent was not mounted between the markers, the device was not used.The procedure was successfully completed when the patient was treated with a non-abbott 2.5 x 12mm stent system.There was no patient involvement or clinically significant delay in the procedure.No additional information was provided.
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