BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1694329 · Received May 19, 2010

    Report

    Report Number
    2015691-2010-13402
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    February 23, 2010
    Report Date
    April 19, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD OTHER DEVICES IMPLANTED; (B) (4). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION WAS RECEIVED ON 04/23/2010. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF APPROXIMATELY 0.1 MONTHS. ON 04/23/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. PER THE CODE BLUE REPORT: REASON FOR CODE IS CARDIAC ARREST AND HYPOXEMIC RESPIRATORY FAILURE DESPITE MECHANICAL VENTILATION. A (B) (6) GENTLEMAN WHO WAS ADMITTED UNDER DR. (B) (6) SERVICE DEVELOPED MULTI-CATHETER ENDOCARDITIS WHO REQUIRED PACER POCKET EVALUATION AS WELL AS PACER LEAD REMOVAL AND MULTIPLE VALVE REPAIRS WITH DR. (B) (6) HERE AT (B) (6) MEDICAL CENTER. I WAS CALLED INITIALLY ON (B) (6) 2010 TO EVALUATE THE PATIENT WHO APPEARED TO HAVE A COLLAPSED ENDOTRACHEAL BALLOON AND REQUIRED ENDOTRACHEAL TUBE EXCHANGE. THE PATIENT WHO WAS ON TUBE FEEDS HAD APPARENTLY BEEN, THERE WAS EVIDENCE ON REINTUBATION THAT THE PATIENT HAD BEEN ASPIRATING GASTRIC CONTENTS AROUND THE MALFUNCTIONING ENDOTRACHEAL BALLOON. THE PATIENT WAS SUCTIONED ON MULTIPLE OCCASIONS WITH NORMAL SALINE LAVAGES. BUT DESPITE THIS HE REMAINED HYPOXEMIC DESPITE 100% FIO2. ON (B) (6) AT 5:59 IN THE A.M. I WAS CALLED TO COME AND EVALUATE THE PATIENT. THE PATIENT BECAME PULSELESS AND ASYSTOLIC AND CPR WAS INITIALLY STARTED. THE PATIENT WAS INITIALLY GIVEN AN AMP OF EPINEPHRINE. THE VENTILATOR WAS DISCONTINUED AND THE PATIENT UNDERWENT BAG MASK VENTILATION. THE PATIENT WAS NOTED TO BE VERY DIFFICULT TO VENTILATE. DESPITE 12 MINUTES OF TOTAL CPR WITH INTERMITTENT EPINEPHRINE PUSHES EVERY 3 MINUTES THE CODE WAS CALLED AFTER 12 MINUTES, AND THE PATIENT WAS PRONOUNCED DECEASED AT 6:12 IN THE A.M. THROUGHOUT THE EVENING THE PATIENT HAD INITIALLY BEEN STARTED ON VASOPRESSIN AND DOBUTAMINE WITH THE PATIENT'S BLOOD PRESSURE EXTREMELY TENUOUS. HE HAD BEEN PLACED ON VASOPRESSIN AND DOBUTAMINE WITH VERY LITTLE IMPROVEMENT IN HIS BLOOD PRESSURE. DESPITE THIS, THE PATIENT CONTINUED TO BE HYPOXEMIC AND AN EPINEPHRINE DRIP WAS STARTED PER DR. (B) (6) ORDER. HE ULTIMATELY SUCCUMBED TO HIS DISEASE ON (B) (6) 2010 AT 6:12 IN THE A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09K2344

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death