BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2213642 · Received August 16, 2011

    Report

    Report Number
    2015691-2011-16056
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS THE REASON FOR EXPLANT AND OPERATIVE FINDINGS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) = LEAFLET TEAR. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS REMOVED DUE TO PROSTHETIC VALVE DYSFUNCTION WITH SEVERE AORTIC INSUFFICIENCY. TEE SHOWED LEFT VENTRICULAR FUNCTION MILDLY DEPRESSED WITH ABOUT 45% EJECTION FRACTION. THE AORTIC VALVE PROSTHESIS WAS SEATED IN PLACE WITHOUT ABNORMAL MOTION BUT THERE WAS A GIANT ECCENTRIC JET RADIATING ALL THE WAY DOWN TO THE BOTTOM THIRD OF THE VENTRICLE. THERE WAS NO DILATION OF THE AORTIC ROOT NOTED. UPON FURTHER INSPECTION OF THE VALVE, THERE WAS APPROXIMATELY A 50% TEAR OF THE RIGHT CORONARY LEAFLET AT THE RIGHT CORNUCOMMISSURAL POST. THERE WAS MINIMAL DEGENERATIVE CHANGE OF THE LEAFLETS OTHERWISE. THE VALVE WAS COMPLETELY EXCISED AND ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS PLACED. THE NEW VALVE WAS WELL SEATED WITHOUT EVIDENCE OF CENTRAL OR PERIVALVULAR LEAK. UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT RETURN OF THE DEVICE, AN EVALUATION CANNOT BE PERFORMED TO CONFIRM THE REPORTED EVENT. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 159 MONTHS, AND REPLACED WITH ANOTHER PERICARDIAL VALVE. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 8A0022

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R