(b)(4).The device was returned for analysis.The reported inflation problem was not confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 determined the reported difficulties appear to be related to circumstances of the procedure.The xience xpedition 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 when retracting the undeployed stent back into the guiding catheter.It this case, it is possible the ifu deviation of re-insertion may have contributed to the reported inflation issues.Although the reported inflation issues could not be replicated during return device analysis it is likely the narrowed inflation lumen caused by the noted inner and outer member stretching in combination with the patient¿s anatomy caused the reported inflation problem.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a lesion in the proximal to mid left anterior descending (lad) artery.The 2.5x48 xience xpedition stent delivery system (sds) was advanced; however, the device was unable to cross the calcified lesion.Pre-dilatation was performed, the device was able to cross.An attempt was made to deploy the stent; however, the balloon could not be inflated, even when the pressure was at 10 atmospheres.The sds was removed and it was confirmed that the stent remained on the sds.The device was re-inserted, but the balloon again failed to inflate.The device was removed and replaced with a non-abbott device to complete the procedure.No additional information was provided.
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