It was reported that that procedure was to treat a lesion in the an left circumflex (lcx) artery.The 2.25x28mm xience sierra stent delivery system (sds) resistance was advanced but resistance was noted near the lesion; therefore, the sds was removed and additional pre-dilatation was performed.The sds was attempted to be advanced again; however, the distal end of the stent was noted to become dislodged and the stent struts were noted to open/flared.Therefore, the sds was removed with difficulty.Another stent was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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The device was returned for analysis.The reported material deformation was confirmed.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.The reported stent dislodgement was not confirmed.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.It was reported that the 2.25x28mm xience sierra stent delivery system (sds) was attempted to be re-advanced.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use 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 into the artery once it has been pulled back into the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as , it is likely the device interacted with the anatomy during advancement to the lesion causing the reported failure to advance.During removal continued interaction with the anatomy and the flared stent likely occurred causing the reported difficulty to remove.The device was returned and the stent dislodgement could not be confirmed as the stent implant was stationary and tight on the balloon between the markers.It is possible the noted stretching of the stent distally identified during return analysis was identified as a stent dislodgement by the account; however, this cannot be confirmed.Additionally, the device was removed and re-inserted against the xience sierra instructions for use.Movement into the artery once a device has been pulled back into the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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