This is being filed to report the atrial septal defect (asd) and treatment.It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr).The mitraclip was successfully implanted.Hours after the procedure, the patient experienced severe right-to-left shunting with a subsequent decline in oxygen saturation in merely hours after the procedure, which resolved after percutaneous iatrogenic atrial septal defect (iasd) closure.No additional information was provided.Details are listed in the attached article: "haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.
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D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.The reported patient effects of perforation (cardiac) and hypoxia (respiratory distress) as listed in the mitraclip system instructions for use (ifu) are known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported perforation could not be determined in this complaint.The reported hypoxia was a cascading effect of the perforation.The reported unexpected medical intervention appears to be due to case specific circumstance as the patient perforation was treated with a closure.Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.
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