Udi: (b)(4).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator). the edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator). in this case, the device was used in an off-label implantation in the native mitral position. as there are no specific ifu or training materials related to mitral procedures, the available training materials were reviewed only for information potentially relevant to the device use.Valve malposition and embolization are known potential complications associated with the transcatheter valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition/embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator. in this case, there was no allegation or indication a product deficiency and/or malfunction contributed to this adverse event.The cause of the malposition is unknown, however may be due to patient factors (mac) and/or procedural related factors. complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Edwards received notification from a field clinical specialist that a 29mm sapien 3 was implanted too atrial. as reported, this was a mitral valve in mac (mitral annular calcification) case.After the 1st valve was implanted, it was determined to be positioned too atrial. a 2nd valve was implanted in a lower position with good results.
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