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 perforation was unable to be determined.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 the 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 iatrogenic atrial septal defect, requiring intervention.It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) grade 4 with enlarged atrium.One clip was implanted with no reported issue, reducing mr to grade 1.After the steerable guide catheter (sgc) was removed from the left atrium, a left to right shunt was observed.After removing the tube and moving the patient from the op table, monitoring showed a saturation of 70% and the patient was in hypoxia.A transthoracic echocardiogram (tte) showed a right to left shunt.The iatrogenic atrial septal defect (iasd) was closed by a 25mm disc.No additional information was provided.
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