It was reported on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.One xtw clip was implanted, reducing mr to a grade of 2.Roughly three months post procedure, the patient returned to the hospital with symptoms of shortness of breath, swelling, and malaise.Echocardiography showed the implanted clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 4+.On (b)(6) 2024, an additional mitraclip procedure was performed.To stabilize the slda, two additional xtw clips were implanted.Mr remained at a grade of 4+.
|
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and a cause for the reported slda cannot be determined.Recurrent mitral valve insufficiency/regurgitation (mr) resulting in dyspnea swelling/edema appears to be due to the slda.Edema/swelling, dyspnea and mitral regurgitation (mr) are known possible complications associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
|