(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It is possible that vessel tortuosity and/or inadvertent mishandling contributed to the reported difficulties, however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect cardiac perforation and vessel perforation or laceration as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
This is filed to report a perforation and intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Vessel tortuosity was noted.A guide wire was advanced and observed to enter the left iliac vein, and not the inferior vena cava.The guide wire was advanced to the pulmonary vein, and then the steerable guide catheter (sgc) was inserted.The insertion site was confirmed through fluoroscopy; however, the sgc tip perforated the bifurcation area between the internal iliac artery and external iliac artery.A decision was made to remove the sgc and abort the procedure.The perforation was surgically sutured for treatment.No clips were implanted, and mr is 4.There was no clinically significant delay in the procedure.No additional information was provided.
|