(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the vessel; the delivery system 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 similar incidents from this lot.The investigation determined that the reported device damaged by another device, material deformation and subsequent treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
|
It was reported that during a procedure of the heavily tortuous, non-calcified, mid left anterior descending (lad) artery and the diagonal artery, the xience sierra stent was implanted without issue.While attempting to remove the non-abbott guide wire in the lad, resistance was met as the wire was jailed under the stent.The wire became detached; the stent was foreshortened and grossly deformed in the vessel.The patient was transferred to surgery, placed on a balloon pump and coronary artery bypass was performed.The patient was reported to be in critical condition, but was being weaned from the balloon pump.No additional information was provided.
|