BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3000312 · Received March 12, 2013

    Report

    Report Number
    2015691-2013-19523
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    April 27, 2012
    Report Date
    February 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPONSE WAS RECEIVED FROM THE SURGEON DESCRIBING THE EVENT: THE AORTA WAS OPENED WITH A LONGITUDINAL AORTOTOMY. THE AORTIC VALVE WAS IDENTIFIED TO BE BICUSPID, SEVERELY CALCIFIED VALVE. THE CUSPS WERE RESECTED AND INITIALLY A 25-MM BIOPROSTHETIC AORTIC VALVE WAS PLACED. THE AORTA WAS APPROXIMATED WITH THE USE OF TWO LAYERS OF PROLENE 4-0 SUTURE WITH THE USE OF TEFLON STRIPS IN THE FASHION OF REDUCTION AORTOPATHY. AFTER METICULOUS DEAIRING, THE CROSS-CLAMP WAS REMOVED AND THE PATIENT WAS GRADUALLY WEANED OFF CARDIOPULMONARY BYPASS MACHINE AND CAME OFF BYPASS. WHILE THAT HAPPENED THE PATIENT HAD FREQUENT VENTRICULAR ECTOPICS GOING INTO VT AS WELL. ON EXAMINATION, THE RIGHT CORONARY ARTERY SEEMED NOT TO BE FILLING PROPERLY. IT HAS TO BE HIGHLIGHTED THAT IT WAS A VERY SMALL VESSEL BEING QUITE CLOSE TO THE AORTIC ANNULUS. IT WAS DECIDED THAT MOST LIKELY THE SIZE OF THE ABOVE BIOPROSTHESIS WAS AFFECTING THE FLOW OF BLOOD INTO THE RIGHT CORONARY ARTERY OSTIUM. THE AORTIC CROSS-CLAMP WAS REPOSITIONED AND THE HEART WAS AGAIN ARRESTED WITH CARDIOPLEGIC SOLUTION ON BYPASS. THE AORTOPATHY WAS OPENED AND THE 25-MM BIOPROSTHESIS WAS REMOVED. A NEW 23-MM CARPENTIER- EDWARDS PERIMOUNT BIOPROSTHESIS WAS SECURED WITH PLEDGETED AND GRAFTED WITH NON-INVERTING SUTURES. THE AORTOTOMY WAS CLOSED WITH THE USE OF A SMALL PERICARDIAL PATCH AT THIS TIME. THE PATIENT WAS GRADUALLY WEANED OFF CARDIOPULMONARY BYPASS MACHINE AND CAME OFF BYPASS VERY WELL. NO SIGNIFICANT INOTROPIC SUPPORT WAS NECESSARY AND THE RIGHT CORONARY ARTERY WAS NOW FILLING WITH GOOD OUTFLOW. 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, IT APPEARS THAT THIS EVENT WAS RELATED TO A SIZING ISSUE; THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. 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. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. NO OTHER DETAILS WERE PROVIDED.

    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 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 DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103356 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R