The device was not returned for evaluation.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 and/or complaints from this lot.The investigation determined the reported complaints and patient effects appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The xience xpedition device referenced is filed under a separate medwatch report number.
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It was reported that during a left anterior descending and left circumflex coronary artery intervention that was mildly tortuous and 90% stenosed, after pre-dilatation, the 2.75x48mm xience xpedition stent was advanced to the lesion and stent deployment initiated; however, during balloon inflation, the balloon would not go past 6 atmospheres (atm) and then failed to deflate.The device was attempted to be removed; however, it became stuck and the shaft separated.The stent became shortened but remained on the delivery system in the patient.A 2.5x12mm nc trek was advanced to assist with removal of the stent delivery system; however, that device also became stuck and the shaft separated.The patient was sent for coronary artery bypass graft surgery, where the devices, including the stent, were successfully removed.There was no additional information provided.
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