Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Same case as mdr# 2134265-2015-09390 it was reported that vessel perforation occurred.Vascular access was obtained through the right femoral artery.The de novo, >85% stenosed d1 bifurcation and >75% stenosed d1 ostium, were located in a severely tortuous and moderately calcified proximal to mid left anterior descending artery (lad).A 1.25mm rotalink plus was inserted inside the patient's body after a rotawire floppy crossed the lesion.During procedure, rotablation was done at 160,000rpms; however, vessel perforation of the lad was noted on angiography.The perforation was then covered with a 2.8x16mm non bsc stent graft.Subsequently, patient suffered hypotension.An 8fr with 40cc intraaortic balloon pump (iabp) was passed through the right femoral artery and maintained the balloon at 1:1 augmentation.Two dimensional echocardiogram was done which then observed pericardial effusion.Pericardial centesis was then done and aspirated 100ml if blood.The mid lad was then stented with a 2.5x16mm non bsc drug eluting stent (des) deployed at 14atm fro 25secs, overlapping the stent graft.Subsequently, angiography was again done which revealed a thrombus in the stent graft.A balloon was passed and the stent graft was dilated with a 2.5x12mm nc balloon catheter at 6atm for 15seconds.Heparin 2500 was then injected and angiography observed a small leak in the thrombolysis in myocardial infarction (timi) 2 flow.The physician then decided to send the patient for emergency coronary artery bypass grafting (cabg) due to the persistent leak through the perforation.The patient was then shifted to cardiac transplantation (ctot).There were no further patient complications reported and the patient's condition was stable.
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