(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombus is listed in the mitraclip system instructions for use, as a known possible complication associated with mitraclip procedures.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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This is filed to report the thrombus.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with an mr grade of 4.The steerable guiding catheter (sgc), was advanced; however, a clot was seen on the right atrial septal wall.The sgc was removed and the procedure was aborted.As the patient was given heparin at the beginning of the procedure, no treatment was reported.There was no reported adverse patient effect.Mr was not treated and remains at 4.No additional information was provided.
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