It was reported that the procedure was to treat a heavily calcified lesion in the moderately tortuous left anterior descending (lad) coronary artery.A rotablator was used and balloon angioplasty was performed.The 3.00x12 mm xience sierra stent delivery system (sds) failed to cross so pre-dilatation was performed with a cutting balloon.The xience sierra sds was reinserted and the stent was implanted at 16 atmospheres.Upon removal, blood was noted inside the balloon, indicating a rupture.There were no adverse patient effects and there was no reported 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the device was reinserted into the patient.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported difficult to advance and material rupture appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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