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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It was reported that during preparation of a 2.50x15mm xience skypoint drug eluting stent (des), the sealed and undamaged chipboard box of the des was opened for use when it was noted that the inner foil package had a tear in it.Sterility was unknown, therefore the device was discarded and not used in the patient.A new skypoint was used to successfully complete the procedure.There was no patient involvement and no clinically significant delays in the procedure.No additional information was provided.
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