Related manufacturer reference number: 2648612-2021-00034.On (b)(6) 2021, a 23mm regent mechanical heart valve was selected for implant.Both leaflets of the valve became detached during typing of the valve sutures and fell into the left ventricle (lv) cavity.The valve was removed and both leaflets were retrieved from the lv; neither leaflets were reported to be fractured.A new 21mm regent mechanical heart valve was then implanted.As the physician was starting anatomy closure, one leaflet detached and fell into the lv cavity.The 21mm valve was also explanted and the leaflet was retrieved from the lv cavity; this leaflet was reported to have been fractured.A new competitor's on-x was successfully implanted.The physician alleged an increased pump time and the patient was "critical" after the procedure.Post-operatively, the patient was reported to be in stable condition.
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The reported event of dislodged leaflets could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that a smaller, 21mm valve, was subsequently attempted to be implanted.This is possible evidence of oversizing.Please note, per the instructions for use, artmt600080902, rev.B, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm regent¿ mechanical heart valve sizes, use the smaller size sjm regent¿ mechanical heart valve.".
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