EDWARDS HEART VALVE SIZER

Additional Manufacturer Narrative

H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION IS IN PROCESS. 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 THAT DURING SIZING THE ANNULUS WITH THE MAGNA EASE SIZER MODEL 1133, THE METAL ARM NEAR THE CYLINDRICAL SIZER BROKE WITH A SLIGHT TWIST AND THE CYLINDRICAL SIZER ENDED UP IN THE LEFT VENTRICLE. THE PERFUSION TIME IN EXTRACORPOREAL CIRCULATION (ECC) WAS PROLONGED BETWEEN 20 AND 30 MINUTES TO RECOVER THE BROKEN PIECE.

Additional Manufacturer Narrative

CORRECTED INFORMATION IN SECTION H6 (TYPE OF INVESTIGATION): THE CODE "4112 - ANALYSIS OF INFORMATION PROVIDED BY USER/THIRD PARTY" WAS REMOVED; AND H6 (HEALTH EFFECT - CLINICAL CODE): THE CODE "4580 - INSUFFICIENT INFORMATION" WAS REPLACED BY CODE "4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS".

Additional Manufacturer Narrative

CORRECTED DATA FOR SECTION E1. ADDED INFORMATION TO SECTION B5 AND H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION). H11. ADDITIONAL NARRATIVE/DATA: THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR FURTHER INVESTIGATION, AND NO IMAGES OR MEDICAL RECORDS WERE PROVIDED. 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. BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS UNABLE TO BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem

EDWARDS RECEIVED NOTIFICATION THAT DURING SIZING THE ANNULUS WITH THE MAGNA EASE SIZER MODEL 1133, THE METAL ARM NEAR THE CYLINDRICAL SIZER BROKE WITH A SLIGHT TWIST AND THE CYLINDRICAL SIZER ENDED UP IN THE LEFT VENTRICLE. THE PERFUSION TIME IN EXTRACORPOREAL CIRCULATION (ECC) WAS PROLONGED BETWEEN 20 AND 30 MINUTES TO RECOVER THE BROKEN PIECE. THE PATIENT DID NOT SUFFER ANY INJURY OR ADVERSE EVENT. THE 3300TFX VALVE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS NOTED AS TO BE DOING WELL.

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION D9 (DEVICE AVAILABILITY), E1 (TELEPHONE NUMBER) AND H6 (TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSIONS). UPDATED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION): THE CODE "4117 - DEVICE NOT ACCESSIBLE FOR TESTING" WAS REMOVED AND REPLACED BY "10 - TESTING OF ACTUAL/SUSPECTED DEVICE); H6 (INVESTIGATION FINDINGS); THE CODE "180 - MECHANICAL PROBLEM IDENTIFIED" WAS REPLACED BY "140 - WEAR PROBLEM"; AND H6 (INVESTIGATION CONCLUSIONS): THE CODE "4315 - CAUSE NOT ESTABLISHED" WAS REMOVED AND REPLACED BY "22 - END OF LIFE PROBLEM IDENTIFIED". H11. ADDITIONAL NARRATIVE/DATA: PRODUCT WAS RETURNED TO EDWARDS FOR EVALUATION. CUSTOMER REPORT OF BROKEN SIZER ISSUE WAS CONFIRMED. AS RECEIVED, BARREL END OF THE 21MM SIZER WAS BROKEN OFF AT THE ROD TO SIZER JUNCTION AND WAS RETURNED WITH DEVICE. BROKEN PIECES MATCHED UP. NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE FOUND. IMAGES PROVIDED TO EDWARDS WERE REVIEWED. IMAGES WERE CAPTURED OF WHERE THE 1133 BARREL FRACTURED, THE DISCOLORATION AND THE BARREL FRACTURING INTO TWO PIECES IS A RESULT OF FATIGUE. DISCOLORATION IS AN INDICATION OF THE BARREL SURPASSING THE NECKING STAGE BEFORE THE BARREL FRACTURED INTO TWO SEPARATE MATING PIECES. IF THE MATERIAL WAS BRITTLE THEN THE BARREL WOULD HAVE FRACTURED INTO MANY DIFFERENT PIECES INSTEAD OF TWO BODIES. DUE TO THE OBSERVED DISCOLORATION AND CLEAN FRACTURE POINT, IT WAS CONFIRMED THAT THE SIZER FRACTURED DUE TO EXCESSIVE WEAR AND TEAR. A DEVICE HISTORY RECORD (DHR) AND LOT HISTORY RECORD (LHR) REVIEW WAS UNABLE TO BE PERFORMED AS NO LOT NUMBER HAS BEEN PROVIDED. CURRENT RISK MITIGATIONS INCLUDE MATERIAL SPECIFICATIONS, VISUAL INSPECTIONS, AND IFU WARNINGS, CAUTIONS, AND INSTRUCTIONS. 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. BASED ON THE INFORMATION AVAILABLE THE MOST LIKELY ROOT CAUSE IS WEAR & TEAR OF THE SIZER. AN EDWARDS DEFECT HAS NOT BEEN CONFIRMED. THEREFORE, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.