D
Patient 1
HEART VALVE EXPLANTED DUE TO DEFECT. "INDICATION FOR PROCEDURE: THIS (B)(6) Y/O GENTLEMAN FIRST UNDERWENT AN AORTIC VALVE REPLACEMENT WITH A TRIFECTA VALVE IN EARLY 2017. IN (B)(6) 2019, HE PRESENTED HERE WITH ENDOCARDITIS OF HIS TRIFECTA VALVE AND UNDERWENT A REDO AORTIC VALVE REPLACEMENT BY THIS SURGEON. A MEDIUM SIZED PERCEVAL VALVE WAS INSERTED. THE PT DID WELL AFTER THIS AND INTRAOPERATIVE ECHO SHOWED THE VALVE TO BE WELL SEATED WITH NO PERIVALVULAR LEAK AND A PRE-DISCHARGE ECHO ALSO SHOWED THAT THE VALVE WAS FUNCTIONING WELL WITH NO PERIVALVULAR LEAK. THE PT DID WELL FOR SEVERAL MONTHS AND AROUND 3 WEEKS AGO DEVELOPED SHORTNESS OF BREATH AND WAS FOUND TO HAVE BILATERAL PULMONARY INFILTRATES. HE WAS WORKED UP BY A PULMONOLOGIST AND AN ECHO WAS DONE SHOWING A SIGNIFICANT PERIVALVULAR LEAK AROUND THE PERCEVAL VALVE. HE WAS ADMITTED TO OUR HOSP AND HE WAS WORKED UP INCLUDING A TRANSESOPHAGEAL ECHO AND A CTA, WHICH DEMONSTRATED THAT THERE WAS A LARGE POSTERIOR PERIVALVULAR LEAK. THE CTA INDICATED THAT A PORTION OF THE VALVE WAS MISSING AND APPEARED TO BE LOCATED IN THE RIGHT COMMON ILIAC ARTERY, WHERE I WAS NOT CAUSING ANY FLOW OBSTRUCTION. THE PT WAS IN MODERATE CONGESTIVE HEART FAILURE, BEING CONTROLLED WITH LASIX. HE HAS HAD PREVIOUS CORONARY ANGIOGRAPHY DEMONSTRATING THAT HE HAS MID-TO-MODERATE CORONARY ARTERY DISEASE WITH NO SIGNIFICANT LESIONS. THE VALVE WAS REMOVED AND A NEW VALVE PLACED. FDA SAFETY REPORT ID# (B)(4).