Description of Event or Problem · 1
HEART VALVE REMOVED FROM PT WAS TREATED BY HOSP AS A "SPECIMEN" AND WAS DISCARDED SHORTLY AFTER ITS REMOVAL. THE ST JUDE VALVE WAS A CLASS III MEDICAL DEVICE. ACCORDING TO RPTR, HOSP, AS A "USER FACILITY," WAS OBLIGATED TO COMPLY WITH THE FDA'S MEDICAL DEVICE REPORTING REGULATIONS, WHICH CONTEMPLATE, AT THE VERY LEAST, THE RETENTION OF EXPLANTED DEVICES AND THEIR RETURN TO THE MFR FOR EXAMINATION. MOREOVER, WHEN THE VALVE WAS REMOVED THE SURGEON DIAGNOSED A "PROSTHETIC AORTIC VALVE DYSFUNCTION," AND NOTED THAT THE VALVE HAD DEHISCED. GIVEN THE CONDITION OF THE VALVE AS DESCRIBED IN THE MEDICAL RECORDS AND PT'S SERIOUS INJURY AND RESULTING DEATH SEVERAL DAYS LATER, HOSP WAS CLEARLY FACED WITH MDR REPORTABLE EVENTS. HOSP SHOULD HAVE SUBMITTED THE REQUIRED REPORTS TO BOTH THE FDA AND ST JUDE, THE MFR, WTIHIN TEN (10) WORKING DAYS OF THESE EVENTS. INSTEAD THE CLASS III DEVICE WAS TREATED LIKE A TISSUE SAMPLE ("SPECIMEN") AND DESTROYED. IN FACT, THIS PARTICULAR VALVE MAY HAVE BEEN SUBJECT TO A RECALL NOTICE FROM THE MFR - A NOTICE WHICH HOSP WOULD HAVE RECEIVED SEVERAL MONTHS EARLIER. RPTR IS CONTINUING TO EVALUATE THE POTENTIALLY DEVASTATING IMPACT OF HOSP'S DESTRUCTION OF THIS DEVICE UPON PT'S RIGHTS.