BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3170291 · Received June 14, 2013

    Report

    Report Number
    2015691-2013-20349
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IN THIS CASE, IT WAS REPORTED THAT THIS PATIENT HAD SURGERY FOR ENDOCARDITIS APPROXIMATELY 3 MONTHS PRIOR TO IMPLANT OF THE SUBJECT DEVICE. IT IS LIKELY THAT THE INFECTED MITRAL VALVE WAS RELATED TO THE PATIENT'S PREVIOUS CASE OF ENDOCARDITIS. THE SURGEON ALSO INDICATED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE 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 REPORTED THAT THE PROSTHETIC MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 MONTH DUE TO RECURRENT ENDOCARDITIS. PER THE OP REPORT, THIS PATIENT WAS FIRST SEEN 6 WEEKS PRIOR FOR ENDOCARDITIS, WHICH PUT HIM INTO SHOCK, PULMONARY EDEMA, AND RENAL INSUFFICIENCY. HE WAS OPERATED ON AS AN EMERGENCE AND UNDERWENT AORTIC VALVE REPLACEMENT AND DEBRIDEMENT OF A SEPTAL ABSCESS. HE WAS PLACED ON PENICILLIN AND THEN ALMOST 3 WEEKS FOLLOWING SURGERY, DEVELOPED SEVERE MITRAL REGURGITATION (MR) AND RECURRENCE OF HEART FAILURE, AS WELL AS HEMOLYSIS. THUS, HE WAS TAKEN BACK AT THAT TIME FOR MITRAL VALVE REPLACEMENT WITH THE SUBJECT DEVICE. HE NOW REPRESENTED WITH SEVERE MR AND MODERATELY SEVERE AORTIC REGURGITATION, REQUIRING RE-REPLACEMENT OF BOTH VALVES. ONLY THE MITRAL VALVE WILL BE ADDRESSED IN THIS REPORT. DURING EXPLANTATION OF THE MITRAL VALVE, THERE WAS VEGETATION ANTERIORLY AT "12 O'CLOCK AND AN ADDITIONAL ONE AT ABOUT 9 O'CLOCK." THE PROSTHESIS WAS EXPLANTED AND THOSE 2 AREAS WERE DEBRIDED. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE BETTER THAN EXPECTED. THE SURGEON ADDITIONALLY NOTED THAT THERE WAS NO MALFUNCTION OF THE EXPLANTED EDWARDS MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270915 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-11L4029

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R