It was reported that on (b)(6) 2023, a 21mm epic plus supra aortic valve was chosen for implant.After implanting the valve, the physician noted via transesophageal echocardiography (tee) the valve "appeared to leak" and had difficultly closing.A decision was made to explant the valve.The 21mm epic plus supra aortic valve was replaced with a 19mm epic plus supra aortic valve.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient status was reported as stable.
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The reported event of regurgitation could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with a non-structural valve dysfunction.A non-structural valve dysfunction (nsvd) is a known potential complication of valve replacement surgery as outlined in the instructions for use.Nsvd is commonly attributed to implant-related technical factors such as inappropriate sizing or positioning, entrapment by suture, stent deformation, or mishandling of the leaflet tissue.In this case there is no evidence of entrapment by suture, or stent deformation that could explain the observed intra-operative valvular dysfunction.A smaller valve (19mm instead of 21mm) was successfully implanted, but there is no indication of inappropriate sizing.Temporary distortion of the stent due to external forces following closure where the stent is not permanently deformed may also potentially explain the observed intraoperative valvular dysfunction.However, since it is not possible to determine whether there was any temporary intra-operative stent deformation and none of the other potential causes for nsvd could be confirmed, the exact cause of the observed intra-operative valvular regurgitation cannot be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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