BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2922922 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19150
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 21, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE, SAME MODEL AND SIZE. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A COPY OF THE OP REPORT WAS RECEIVED WHICH INDICATES THAT THIS PATIENT PRESENTED WITH MITRAL STENOSIS AND MITRAL REGURGITATION OF HER NATIVE VALVE AND WAS REFERRED FOR MITRAL VALVE REPLACEMENT. DURING THE PROCEDURE, THE EDWARDS VALVE WAS LOWERED INTO THE MITRAL ANNULUS. EVEN THOUGH THE VALVE EASILY FIT, IT WAS NOTED THAT THE BACK POST DID NOT SIT WELL; THEREFORE, THIS DEVICE WAS REMOVED AND A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. THIS TIME AROUND, INSPECTION WAS QUITE SATISFACTORY. EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE ISSUE WAS RECOGNIZED PRIOR TO THE PATIENT BEING REMOVED FROM CARDIOPULMONARY BYPASS. THEREFORE, THE PROCEDURE TIME WAS NOT SIGNIFICANTLY EXTENDED. BASED ON THIS INFORMATION, THERE DOES NOT APPEAR TO BE ANY MALFUNCTION OR SERIOUS INJURY RELATED TO THE SUBJECT DEVICE. NO FURTHER ACTIONS ARE POSSIBLE.

    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 AT IMPLANT. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE, SAME MODEL AND SIZE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27793 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention