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 reported perforation (atrial: no treatment) associated with the atrial septal defect (asd) appears to be due to procedural circumstances (device interacting with patient pathology/ morphology).The reported patient effect of perforation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported minor 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.
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This is filed to report an atrial perforation.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted the patient had an atrial septal aneurysm.One clip was successfully implanted, reducing mr to a grade of 1.However, after removal of the steerable guide catheter (sgc), a bi-direction shunt was observed.The physician stated the shunt presented no clinical problem; therefore, no treatment was performed.There was no clinically significant delay in the procedure.No additional information was provided.
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