EDWARDS HEART VALVE SIZER

Additional Manufacturer Narrative

H11: ADDITIONAL MANUFACTURER NARRATIVE: PRODUCT WAS RETURNED TO EDWARDS FOR EVALUATION. CUSTOMER REPORT OF FRAGMENTED SIZER WAS CONFIRMED. AS RECEIVED, THE BARREL END OF THE SIZER HAD BROKEN OFF AT ROD TO SIZER JUNCTION. CROSS SURFACES OF THE BROKEN BARREL END AREA WERE UNEVEN. BROKEN OFF FRAGMENTS OF BARREL END APPEARED TO MATCH UP. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. SIZERS ARE RE-USABLE INSTRUMENTS THAT ARE RE-STERILIZED AFTER EACH USE. THEY ARE OFTEN USED UNTIL VISIBLE DAMAGE IS DETECTED. THEY ARE TYPICALLY INSPECTED BY THE OPERATIVE TEAM DURING CLEANING AND PRIOR TO PACKAGING FOR RE-STERILIZATION AND FRACTURES CAN BE VISUALLY DETECTED. NO CONFIRMATION OF SIZER INSPECTION PRIOR TO USE WAS RECEIVED. IT IS UNKNOWN HOW MANY STERILIZATION CYCLES THE SIZER HAD UNDERGONE PRIOR TO THIS EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER BASED ON THE INFORMATION AVAILABLE, IT IS LIKELY THAT THE FRAGMENTATION IS DUE TO WEAR AND TEAR. AN EDWARDS DEFECT HAS NOT BEEN CONFIRMED.

Additional Manufacturer Narrative

H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS THE DEVICE REQUEST IS ONGOING. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem

EDWARDS RECEIVED NOTIFICATION FROM BRAZIL THAT, DURING A MITRAL VALVE REPLACEMENT, THE PLASTIC PART OF A CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER MODEL 1173R29 FRAGMENTED INTO SEVERAL PIECES INSIDE THE PATIENT'S THORACIC CAVITY, WHILE THE DOCTOR WAS PERFORMING THE MEASUREMENT. REPORTEDLY, SOME OF THE BROKEN PARTS FELL INSIDE THE PATIENT AND THEY WERE QUICKLY REMOVED WITH THE HELP OF TWEEZERS. IT WAS FURTHER CLARIFIED THAT THE DEVICE HAD BEEN IN USE FOR 6 MONTHS APPROXIMATELY AND THE MEDICAL TEAM DID NOT CONFIRM THEY CARRIED OUT AN INSPECTION PRIOR TO ITS USE. AS REPORTED, THE ADVERSE EVENT DID NOT LEAD TO ANY INJURY OR WORSENING OF THE PATIENT'S CONDITION, DEATH; AND NEITHER TO AN EXTENDED HOSPITALIZATION PERIOD. THE PATIENT WAS NOTED AS TO BE DISCHARGED WITHOUT PRESENTING COMPLICATIONS IN THE IMMEDIATE POST-OPERATIVE PERIOD.