(b)(4).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 other incidents from this lot.It should be noted that the xience prime ll everolimus eluting coronary stent system instructions for use (ifu) states: deflate the balloon by pulling negative on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer.After successful withdrawal of the balloon from the deployed stent, should any resistance be felt at any time when withdrawing the stent delivery system into the guide catheter, remove the entire system as a single unit.Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that a sufficient time was not allowed to fully deflate the balloon resulting in compromising the inflation /deflation lumen thus resulting in the reported deflation problem and the reported difficult to remove as the partially deflated balloon got stuck at the tip of the procedural sheath.Manipulation of the device ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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