Description of Event or Problem · 1
ON (B) (6) 2010, A PT DEATH WAS REPORTED TO CORMATRIX CARDIOVASCULAR. THE PHYSICIAN STATED THAT THIS WAS A VERY HIGH RISK PEDIATRIC CASE WHO HAD SEVERE, COMPLEX HEART DEFECTS. THE PT WAS DIAGNOSED WITH HYPOPLASTIC LEFT HEART SYNDROME AND SEVERE AORTIC ATRESIA. ON (B) (6) 2010, THE PT UNDERWENT A NORWOOD PROCEDURE AND RECONSTRUCTION OF THE AORTA AND PULMONARY ARTERY. THE CORMATRIX ECM WAS USED FOR PULMONARY ARTERY RECONSTRUCTION AND AORTIC PATCH RECONSTRUCTION. THE PHYSICIAN REPORTED THAT FOLDS IN THE ECM DEVELOPED AND DURING REMODELING, THE FOLDS THICKENED. ON (B) (6) 2009, THE PT RETURNED FOR RE-OPERATION AND DIED DURING SURGERY FROM PROGRESSIVE HEART DYSFUNCTION. THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PRODUCT WAS NOT RETURNED TO CORMATRIX FOR INVESTIGATION. IT COULD NOT BE DETERMINED WHETHER THE CORMATRIX ECM CONTRIBUTED TO THE PT'S DEATH. AS THE PHYSICIAN STATED, THE PEDIATRIC PT HAD VERY SEVERE HEART DEFECTS.