BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3051482 · Received April 10, 2013

    Report

    Report Number
    2015691-2013-19786
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH) AND INSUFFICIENCY. ACCORDING TO THE OP REPORT, IT WAS NOTED THAT THE FIBROUS INGROWTH WAS LIKELY RESPONSIBLE FOR THE GRADIENT AS THE VALVE LEAFLETS LOOKED REASONABLE. FURTHERMORE, THE AREA OF THE PERIVALVULAR LEAK WAS NOTED AND EASILY IDENTIFIED AS THERE WAS BUILT-UP CLOT IN THIS REGION. UNFORTUNATELY, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITHOUT THE SAMPLE DEVICE OR 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 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS, 10 MONTHS DUE TO SEVERE SUBVALVULAR AORTIC STENOSIS AND MODERATE AORTIC INSUFFICIENCY (AI). PER THE OP REPORT, TEE SHOWED SEVERE AORTIC STENOSIS WITH A MEAN GRADIENT OF 40 AND MODERATE AI FROM A REASONABLE PERIVALVULAR LEAK. UPON INSPECTION OF THE VALVE, THE AREA OF THE PERIVALVULAR LEAK WAS NOTED AND EASILY IDENTIFIED AS THERE WAS BUILT-UP CLOT IN THIS REGION. THE VALVE SUTURES WERE VERY LOOSE. FIBROUS INGROWTH WAS ALSO IDENTIFIED DURING REMOVAL OF THE VALVE. IT WAS NOTED THAT THIS WAS LIKELY RESPONSIBLE FOR THE GRADIENT AS THE VALVE LEAFLETS LOOK REASONABLE. THE VALVE WAS, HOWEVER, QUITE SMALL FOR THE LARGE ANNULUS. UNDERNEATH THE VALVE, THERE WAS CONSIDERABLE FIBROSIS, AND THIS WAS CAREFULLY ENDARTERECTOMIZED. THE EXPLANTED DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. POSTOP ECHO SHOWED NOW PERIVALVULAR LEAK WITH A WELL FUNCTIONING AORTIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148511 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R