This is filed to report atrial septal defect (asd), drop in blood pressure, requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade of 4.One clip was implanted with no reported issue, reducing mr to grade 1-2.Blood pressure dropped after removing the steerable guide catheter (sgc) from the left atrium to the right atrium.An asd closure device was used with no reported issue, blood pressure returned and the patient's hemodynamic was stabilized.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.
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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.The investigation was unable to determine a cause for the reported perforation.The hypotension appears to be a cascading effect of the asd.Perforation and hypotension are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.
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