This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 myocardial infarction death event for the sapien 3 ultra transcatheter heart valve in the mitral position.The ''time to event'' (tte, in days) for this event was 0.0.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(4).Per the instructions for use (ifu), thrombus formation, plaque dislodgement, and embolization of calcific materials that may result in myocardial infarction (mi) are potential adverse events associated with the overall transcatheter mitral valve replacement (tmvr) procedure.The ifu states that caution should be exercised when implanting a bioprosthesis in patients with clinically significant coronary artery disease.Mi related to a transcatheter heart valve (thv) procedure will manifest intra-procedurally or in the immediate post-operative period and is typically due to a combination of patient and/or procedural factors.As defined in the valve academic research consortium (varc) publication on tavr complications, the peri-procedural interval is inclusive of all events that begin within 72 hours of the index procedure.Mi's that occur after the peri-procedural period (>72hrs) are typically related to the patient's underlying coronary disease.This applies to tmvr patients, as well as tavr patients.There are multiple patient factors that could put the patient at risk for mi during a thv procedure, including significant underlying coronary artery disease and atherosclerotic deposits along the cardiac anatomy.Displacement of deposits with embolization of debris into one of the arteries can result in this complication.The edwards thv manuals advise the operator on pre-procedure assessment of the cardiac anatomy.Physicians are extensively trained by edwards before they are qualified to use the thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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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