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 associated with the large fossa ovalis perforation and 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, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention 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 a perforation requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.Two ntw mitraclips were implanted successfully, reducing mr to grade 1.There was no issue with the mitraclip system during use.After removing the steerable guide catheter (sgc), it was noticed that there was a large hole in the fossa ovalis of the septum.The hole was closed with an atrial septal defect (asd) occluder.No additional information was provided.
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