(b)(4).The patient developed some angina and st elevation from this occurring.The artery was dissected as well.At this point, it was felt that further intervention would not be possible and the procedure was terminated at that point.The patient was stable and symptoms improved over the subsequent 10-15 minutes.The patient was started on nitrates and given beta blockers and morphine.The patient was managed medically over the next 24-48 hours.The patient was discharged (b)(6) 2015.No additional information was provided.Concomitant medical products: guide wire: wiggle, guide catheter: ikari left 3.75 guide catheter.Attachment: medwatch report (b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation was unable to determine a conclusive cause for the reported patient effects however the balloon rupture, difficulty removing the device, balloon separation and treatments appear to be related to operational context of the procedure.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of intimal dissection, angina, embolism and myocardial infraction are listed in the nc trek rx coronary dilatation catheter instructions for use (ifu) as known patient effects that may be associated with use of the device.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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User facility medwatch received which states: the patient had recently undergone a coronary artery bypass grafting (cabg) procedure and was discharged.He was readmitted later that same month with st elevation myocardial infarction from an occlusion of the vein graft to the ramus intermedium.That same day, patient went to central venous line (cvl) emergently for ptca and aspiration thrombectomy.A couple of days later, back to cvl for attempted (percutaneous coronary intervention) pci to the diagonal branch which was unsuccessful.2 balloons ruptured and there was embolization of balloon material that occluded flow in the diagonal.There was also dissection of the diagonal.The procedure was aborted.The patient went to have a lateral myocardial infarction secondary to the diagonal going down.Medical management was used.He was discharged soon after.Newly reported information indicates that the procedure was to treat a lesion in the diagonal with a fair amount of calcification in the left anterior descending artery into the diagonal artery.An unsuccessful attempt was made to pre-dilate the ostial diagonal.Multiple balloons were used; a 1.5mm and 2mm unspecified compliant balloon as well as a 2mm and 2.25x8mm trek rx noncompliant (nc) balloon.The 2.25x8mm nc trek ruptured and would not come back into the guide catheter.Significant effort was required to pull the balloon into the guide catheter.The balloon finally was removed and it was noted that a piece of the balloon tore off and occluded flow in the diagonal artery closing down the diagonal artery.
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