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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, moderately tortuous and 85% stenosed anatomy resulting in the reported difficult to advance.Interaction/ manipulation of the device resulted in compromising the stent such that during inflation ultimately resulted in the reported unintended system motion (stent dislodged during inflation).The treatment appears to be related to the operational context of the procedure as a 3.5x23mm xience xpedition stent was implanted over the first stent, which was at least partially in the target lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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It was reported that the procedure was performed to treat a lesion in the heavily calcified, moderately tortuous, 85% stenosed proximal left anterior descending coronary artery.After facing resistance with the anatomy, a 3.5x23mm xience xpedition stent dislodged during inflation, so a 3.5x23mm xience xpedition stent was implanted over the first stent, which was at least partially in the target lesion.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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