Medtronic received information that the patient presented with severe tricuspid regurgitation measured on echocardiogram, a dilated tricuspid annulus, extreme shortness of breath, an enlarged heart, and recent onset of rapid atrial fibrillation (afib).The physician noted that the patient had a very thin anterior leaflet, which was shorter than normal and likely contributed to the tricuspid regurgitation.The physician attempted to repair the native tricuspid valve with this annuloplasty ring.The physician placed the device with interrupted sutures and secured these with 2-0 ethibond sutures.The physician stated that this did not look good on a saline test and that there was leakage from redundant tissue on the posterior leaflet.The physician placed a 6-0 prolene suture on a cleft opposite the septal annulus.This improved coaptation, but there was still significant leakage.The physician explanted the device and closed the septal side with two pledgeted 4-0 sutures to create a bicuspid leaflet.Significant tricuspid regurgitation remained, so the physician successfully implanted a medtronic bioprosthetic valve in the tricuspid position.No further adverse patient effects were reported.
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Conclusion: investigation results indicated that there are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate result.This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.In this case, this event is attributed to the native valve being unrepairable as the surgical valve replacement was performed.
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