Description of Event or Problem · 1
ON (B)(6) 2013, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING THE USE OF A CORMATRIX ECM DEVICE AND PATCH DEHISCENCE. DETAILS OF THE EVENT ARE PROVIDED BELOW. A CASE STUDY TITLED, "TRANSESOPHAGEAL 3-DIMENSIONAL ECHOCARDIOGRAPHY GUIDED CLOSURE OF A GERBODE SHUNT DUE TO CORMATRIX PATCH DEHISCENCE," WAS DISCOVERED THROUGH A ROUTINE PUBMED SEARCH. THE MANUSCRIPT WAS RECEIVED BY THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY ON 01/24/2013: THUS, THIS EVENT OCCURRED PRIOR TO THIS DATE. THE PT HAD SYMPTOMATIC MITRAL STENOSIS DUE TO SEVERE DYSTROPHIC CALCIFICATION OF THE MITRAL ANNULUS, NECESSITATING A MITRAL VALVE REPLACEMENT PROCEDURE. ON AN UNK DATE, THE CORMATRIX ECM DEVICE WAS USED AS PART OF THIS MITRAL VALVE REPLACEMENT PROCEDURE. THE PT UNDERWENT RESECTION OF THE CALCIUM BAR, AND MITRAL VALVE REPLACEMENT WITH A MEDTRONIC, INC. HANCOCK II BIOPROSTHESIS. THE CORMATRIX ECM WAS USED TO RECONSTRUCT THE BASE OF THE HEART, FROM LATERAL TO THE MEDIAL FIBROUS TRIGONE AND VENTRICULAR SEPTUM. POSTOPERATIVELY, THE PT DEVELOPED BIVENTRICULAR FAILURE AND A LOUD MURMUR. A TRANSOESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED A LARGE LEFT VENTRICLE TO RIGHT ATRIAL COMMUNICATION MEASURING 7 X 11 MM, DUE TO DEHISCENCE OF THE CORMATRIX ECM PATCH. DUE TO THE COMPLEXITY OF THIS GERBODE SHUNT, 3D TEE GUIDANCE WAS USED TO CLOSE THE DEFECT PERCUTANEOUSLY, USING A 14 MM AMPLATZER VSD OCCLUDER (AGA MEDICAL CORP). THIS RESULTED IN "TRIVIAL RESIDUAL SHUNT" WITH "SIGNIFICANT CLINICAL IMPROVEMENT" RELATIVE TO THE PT.