Description of Event or Problem · 1
ON (B)(6) 2013, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING A CORMATRIX ECM FOR CARDIAC TISSUE REPAIR DEVICE AND REPORTED EARLY AORTIC ARCH STENOSIS. ON (B)(6) 2013, THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION INDICATING AN INTERVENTION OCCURRED FOR REDO ARCH RECONSTRUCTION. DETAILS OF THE EVENT ARE PROVIDED BELOW. ON (B)(6) 2013, THE PHYSICIAN USED THE CORMATRIX ECM ON A NEONATE PATIENT AS A SMALL PATCH FOR AORTOPLASTY. THE CORMATRIX ECM WAS HYDRATED IN SALINE SOLUTION FOR APPROXIMATELY 5 MINUTES, AND FOLLOWING HYDRATION WAS TRIMMED TO SIZE. THE PATIENT ORIGINALLY HAD 2-3MM ARTERIAL LUMEN, WHICH WERE AUGMENTED TO 5-6MM WITH THE ECM PATCH. THE PHYSICIAN REPORTED THAT FOLLOWING THE SURGERY, NARROWING WAS SEEN PRIMARILY IN THE PERIDUCTAL AREA. THE PHYSICIAN REPORTED THE PATIENT DEVELOPED RECOARCTATION/RECURRENT ARCH OBSTRUCTION. ON (B)(6) 2013, THE PATIENT UNDERWENT BALLOON DILATATION AND ON (B)(6) 2013, THE PATIENT UNDERWENT A SECOND "REDO" ARCH RECONSTRUCTION. THE REOPERATION RECOVERY PERIOD WAS COMPLICATED BY RECURRENT LARYNGEAL NERVE INJURY, BUT THE PATIENT IS OTHERWISE DOING FINE FOLLOWING THE REOPERATION. THE CAUSE OF THE EARLY AORTIC ARCH STENOSIS IS UNKNOWN. 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.