This is filed to report during use of the steerable guide catheter, a clot was noticed requiring aspiration and after the procedure, it was noted that the patient had suffered a stroke.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.The steerable guide catheter (sgc) (lot #10329r419) was advanced and the first clip was implanted.When the second clip delivery system (cds) was being advanced through the sgc, a clot was noted protruding out of the sgc in the left atrium, the cds was still within the sgc, 10 cm from the sgc¿s tip.The cds was retracted back into the introducer and removed while the sgc was being aspirated.A massive clot clogged the port of the sgc and wrapped around the silicone with in the sgc.The patient was on angiomax (bivalirudin) due to heparin induced thrombocytopenia.Dosage was then requested from the physician and it was realized that patient was on approximately 1/100 of the dosage required for the procedure.A bolus of the drug was given to correct it to 100%.The transseptal equipment was also noticed to have clots in its lumen when they noticed the angiomax dosage issue.A new sgc was then used with the same second cds with no issues.The procedure went well once the angiomax dosage was corrected.Two clips implanted, reducing mr to 1-2.After the procedure, when the patient woke up it was noticed that the patient had suffered a stroke.The patient was treated for the stroke and is currently hemiplegic on the right.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, a cause for the reported thrombus could not be determined.The reported stroke appears to be a cascading effect of reported thrombosis.Paresis appear to be resulted from reported stroke.However, the reported patient effects of thrombus and stroke are listed in the instruction for use (ifu), is known possible complications associated with mitraclip procedures.The reported medication required and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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