BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 5076638 · Received September 14, 2015

    Report

    Report Number
    2015691-2015-02405
    Event Type
    Death
    Date Received
    September 14, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 20, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PANNUS/HOST TISSUE OVERGROWTH ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND DEVICE RETURN WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE OF THE EXPLANT AND PATIENT EXPIRATION IS INDETERMINABLE; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 19MM AORTIC PERICARDIAL VALVE, IMPLANTED THREE (3) YEARS, FOUR (4) MONTHS, ONE (1) DAY , WAS EXPLANTED DUE TO PROSTHETIC AORTIC VALVE STENOSIS. THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER IT WAS LEARNED THAT THE EXPLANTED 19MM AORTIC VALVE HAD A THIN LAYER OF PANNUS. DESIRING IMPLANTATION OF A LARGER AORTIC VALVE DURING THE RE-DO SURGERY, THE PATIENT¿S AORTIC ROOT WAS ENLARGED WITH A PERICARDIAL PATCH AND THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM AORTIC PERICARDIAL VALVE. ONCE ECHO VISUALIZATION WAS ACCOMPLISHED, THE 23MM VALVE ¿APPEARED TO BE FUNCTIONING APPROPRIATELY WITH NO PARAVALVULAR LEAK¿. THE PATIENT HAD PERIODIC INSTABILITY OBSERVED AS PERIODS OF PRESSURE AND VOLUME FLUCTUATIONS FROM THE TIME CARDIOPULMONARY BYPASS WAS INITIATED THROUGH THE TIME SHE WAS COMING OFF PUMP. ONCE HER RHYTHM RETURNED, SHE HAD RIGHT HEART FAILURE. THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION SEVERAL TIMES INCLUDING WHEN ATTEMPT TO CLOSE THE CHEST. "EVERY TIME AN ATTEMPT TO CLOSE THE CHEST WAS MADE, THE PATIENT WOULD DEVELOP V FIB." THE PATIENT WAS TRANSFERRED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) IN A TENUOUS STATE, CHEST OPEN AND HIGH DOSE INOTROPES AND PRESSORS. "PATIENT REQUIRE(D) SIGNIFICANT AMOUNTS OF VASO, LEVO, EPI, AND MILLRINONE AS WELL AS MULTIPLE FLUID BOLUSES TO TREAT THE CARDIOGENIC SHOCK. ON POST OPERATIVE DAY ONE (1) THE PATIENT HAD A COUPLE OF VENTRICULAR FIBRILLATION EVENTS THAT SHE WAS CARDIOVERTED OUT OF. ON POST OPERATIVE DAY TWO (2) THE PATIENT DEVELOPED HEART BLOCK AND BECAME PACER DEPENDENT. REQUIRING A HIGHER LEVEL OF CARE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO UNDERGO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). EDWARDS WAS NOTIFIED BY THE HOSPITAL THAT THE PATIENT EXPIRED ON POST OPERATIVE DAY THREE (3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606037 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R