Description of Event or Problem · 1
ON (B)(6) 2013, CORMATRIX CARDIOVASCULAR RECEIVED A COPY OF THE USER FACILITY REPORT # (B)(4) REGARDING AN EVENT INVOLVING THE USE OF A CORMATRIX ECM FOR PERICARDIAL CLOSURE DEVICE RESULTING IN REFORMATION OF AN INTRACARDIAC DEFECT OCCURRING AT (B)(6). DETAILS OF THE EVENT ARE PROVIDED BELOW: IN (B)(6) 2012, THE PT UNDERWENT A REPAIR OF A PARTIAL ANOMALOUS PULMONARY VENOUS CONNECTION AND SECUNDUM ATRIAL SEPTAL DEFECT (ASD) REPAIR. A SINGLE CORMATRIX ECM FOR PERICARDIAL CLOSURE DEVICE MEASURING 7CM X 10CM WAS DIVIDED AND USED FOR A TWO PATCH CLOSURE TECHNIQUE, FOR ASD PATCH AS WELL AS TO BAFFLE THE PULMONARY VEINS TO THE LEFT ATRIUM. POSTOPERATIVELY, A TRANSESOPHAGEAL ECHOCARDIOGRAM PERFORMED IN THE OPERATING ROOM PRIOR TO CLOSING THE PT'S CHEST DEMONSTRATED COMPLETE CLOSURE OF THE ASD WITH NO RESIDUAL DEFECT NOTED, AS WELL AS APPROPRIATE BAFFLING OF THE PULMONARY VEINS TO THE LEFT ATRIUM. A FEW DAYS AFTER THE INITIAL OPERATION, A TRANSTHORACIC ECHOCARDIOGRAM SHOWED MINIMAL LEAKAGE AT THE ASD PATCH AT THE RETROAORTIC REGION. A FEW WEEKS AFTER THIS ECHOCARDIOGRAM SHOWING MINIMAL LEAKAGE, A ROUTINE FOLLOW-UP AS WELL AS AN ER VISIT SHOWED INCREASED RESIDUAL ASD VIA TRANSTHORACIC ECHOCARDIOGRAM. PATCH DEHISCENCE OR DYSFUNCTION OF THE PATCH CONTRIBUTED TO THE INCREASING SIZE OF THE ASD. IT WAS REPORTED ON (B)(4) 2013, THE PT WAS BROUGHT INTO THE OPERATING ROOM FOR ASD REPAIR AND UPON ENTERING THE ATRIUM, DIRECT VISUALIZATION SHOWED THE CORMATRIX PATCH WAS NO LONGER PRESENT AT THE ASD SITE. THE ASD WAS CLOSED USING A BOVINE PERICARDIAL PATCH. DURING REOPERATION, THE PORTION OF THE CORMATRIX PATCH USED TO BAFFLE THE PULMONARY VEINS TO THE LEFT ATRIUM WAS REPORTED TO BE INTACT WITH APPROPRIATE TISSUE DEVELOPMENT. THE CORMATRIX ECM FOR PERICARDIAL CLOSURE IS ONLY INDICATED FOR RECONSTRUCTION AND REPAIR OF THE PERICARDIUM. ALTHOUGH CORMATRIX HAS CLEARANCE FOR USE AS AN INTRACARDIAC PATCH OR PLEDGET FOR CARDIAC TISSUE REPAIR [CORMATRIX ECM FOR CARDIAC TISSUE REPAIR (K063349)] IT WAS THE CORMATRIX ECM FOR PERICARDIAL CLOSURE PRODUCT (K051405) THAT WAS USED ON THIS PATIENT. IT SHOULD BE NOTED THAT THE ECM FOR PERICARDIAL CLOSURE AND THE ECM FOR CARDIAC TISSUE REPAIR ARE IDENTICAL IN COMPOSITION AND MANUFACTURING PROCESSING, WITH THE EXCEPTION OF BEING DIFFERENT SIZES AND HAVING DIFFERENT INDICATIONS FOR USE.