It was reported a xience skypoint 3 x 33 drug eluting stent (des) box was pulled off the shelf, but once opened, a xience skypoint 3 x 23 des was found inside the box.Therefore, the device was discarded and replaced.There was no clinically significant delay in the procedure.No additional information was provided.
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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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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