This is filed to report a perforation.It was reported a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.Two clips were implanted, reducing mr to a grade of 1.Roughly one year post procedure, the patient returned to the hospital with progression of disease.It was noted the two clips remained stable on the leaflets.An additional mitraclip procedure was performed.To treat mr, an additional clip was implanted, reducing mr.Roughly six months post second mitraclip procedure, the patient returned to the hospital with a symptom of shortness of breath.Echocardiography showed one of the three implanted clips had expulsed and embolized into the right coronary artery (rca) ostium and an atrial septal defect (asd) was observed, causing mr to return to a grade of 4.The other two clips were noted to be stable on the mitral valve.Several days post returning to the hospital, the patient underwent mitral valve replacement.The completely detached clip was removed from the rca ostium.For asd treatment, a closure device was implanted.It was noted a hematoma in the left ventricle and a small tissue tear near the rca ostium were observed, requiring treatment with a patch and stitches.Additional information can be found in the attached article titled, "transcatheter mitral valve repair clip embolization to the right coronary artery".
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The device was not returned for analysis.The lot history record (lhr) review was not performed because [[this incident was based on an article review and]] no lot information was provided.Based on the information reviewed, and due to limited information available from the article the cause of the reported perforation cannot be determined.Additionally, the reported patient effect of perforation is listed in the instructions for use and is a known possible complication associated with mitraclip procedures.The reported 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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