This is filed to report a hemorrhage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted and advanced into the right atrium (ra).It was noted that some resistance was felt when inserting the sgc.Approximately three minutes after the sgc was inserted, the patients blood pressure dropped to 60mmhg.Contrast was inserted and it was noticed that in the groin, a ruptured vein occurred.It was suspected that the sgc caused the ruptured vein.The sgc was removed and the bleeding was able to be temporarily covered with a balloon catheter, but the patient had to undergo surgical intervention to treat the ruptured vein.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 the reported issue.A review of the compliant history identified no other incident reported from this lot.Based on information reviewed, a cause for the reported difficulty advancing the steerable guide catheter (sgc) could not be determined.Reportedly, it was noticed that in the groin, a ruptured vein occurred.It was suspected that the sgc caused the ruptured vein.Therefore, the reported hemorrhage appear to be result of reported difficult to insert.Additionally, reported patient effect of hemorrhage is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported additional therapy/nonsurgical treatment, surgical procedure and hospitalization was a result of case specific circumstances as bleeding was able to be temporarily covered with a balloon catheter, the patient was hospitalized and had to undergo surgical intervention to treat the ruptured vein.There is no indication of a product issue with respect to manufacture, design or labeling.
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