BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2874374 · Received December 14, 2012

    Report

    Report Number
    2015691-2012-18858
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 15, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT THE RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. 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. PER CAPA, (B)(4), DATE OF AWARENESS (G4) IS DATE OF COMPLAINT RE-OPEN.

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED DUE AN OVERWHELMING INFECTION WHICH COULD NOT BE CONTROLLED. HOSPITAL RECORDS INDICATE THE SOURCE OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE IS NO INFORMATION TO SUGGEST A MALFUNCTION OF THE EDWARDS DEVICE. AS PREVIOUSLY STATED, THIS PATIENT HAD A HIGH GRADE ENTEROCOCCAL FAECALIS BACTEREMIA 17 DAYS POST VALVE IMPLANT WHERE A TEE WAS NOTED TO BE NEGATIVE. THE DEVICE SERIAL NUMBER HAS NOT BEEN PROVIDED, THEREFORE A MANUFACTURING REVIEW CANNOT BE COMPLETED. HOWEVER, EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE AN EDWARDS DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL AFFAIRS THAT A PATIENT WITH AN IMPLANTED AORTIC BIOPROSTHETIC VALVE PRESENTED TO HOSPITAL WITH RIGHT SIDED WEAKNESS, FOUND TO BE SEPTIC, THE EVENTUALLY EXPIRED ( 4 MONTHS POST IMPLANT). RECORDS INDICATE THIS IS A (B)(6) FEMALE WITH HISTORY OF BIOPROSTHETIC AVR (B)(6) 2012, PAROXYSMAL AFIB, WITH CONSEQUENT R MCA CVA (B)(6) 2012 WITH APHASIA AND LEFT SIDED HEMIPARESIS S/P G TUBE, ENTEROCOCCUS BACTEREMIA S/P IV ABX, AND ASTHMA. DISCHARGE SUMMARY INDICATES PATIENT PRESENTED ON (B)(6) 2012 ( 4 MONTHS POST IMPLANT) WITH R SIDED WEAKNESS AND FOUND TO BE SEPTIC. SHE WAS INITIALLY ADMITTED TO PCU BUT HER BLOOD PRESSURE CONTINUED TO DROP SO SHE WAS TRANSFERRED TO THE ICU ON THE DAY OF ADMISSION. SHE WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS. SHE WAS FLUID RESUSCITATED BUT CONTINUED TO BE HYPOTENSIVE SO WAS STARTED ON PRESSORS. BLOOD CULTURES WERE POSITIVE FOR (B)(6) AND ACINETOBACTER . IT WAS BELIEVED THE SOURCE WAS THE PATIENT'S PICC SHE HAD IN PRIOR TO ADMISSION SO THIS WAS REMOVED. PT WAS ALSO BELIEVED TO HAVE ENDOCARDITIS BUT TEE WAS NOT DONE AS IT WOULD NOT CHANGE MANAGEMENT AS SHE WAS NOT A SURGICAL CANDIDATE. PT'S NEW R SIDED WEAKNESS WAS BELIEVED TO BE DUE TO SEPTIC EMBOLI CAUSING CVA. PT MENTAL STATUS NEVER IMPROVED. PT'S BACTEREMIA WAS UNABLE TO BE CLEARED DESPITE ANTIBIOTICS. SHE HAD PERSISTENT LEUKOCYTOSIS, FEVERS, POSITIVE BLOOD CULTURES, AND WAS UNABLE TO BE WEANED OFF LEVOPHED - THE PATIENT PASSED AWAY. NO INFORMATION TO SUGGEST A MALFUNCTION OF THE EDWARDS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX S-11M4479RF-1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R