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, the cause of the reported coagulopathy was unable to be determined.The reported patient effect of coagulopathy, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.
|
This is filed to report coagulopathy.It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and thick leaflets.Two clips were successfully implanted, reducing mr to a grade of <1.On (b)(6) 2023, it was observed the patient platelets decreased.It was noted that no treatment was performed and the patient did not show any adverse symptoms due to the decrease in platelets.No additional information was provided.
|