BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2001762 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14918
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    September 24, 2009
    Report Date
    February 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ADDITIONAL ATTEMPTS TO OBTAIN THE CAUSE OF DEATH WERE UNSUCCESSFUL, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE RELATIONSHIP OF SUBJECT DEVICE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. IT IS ASSUMED THAT THE DEVICE REMAINS IMPLANTED AS NO EXPLANT INFORMATION WAS MADE AVAILABLE AND THERE IS NO REPORT OF AN AUTOPSY. NO CAUSE OF DEATH HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS LEARNED THROUGH A CLINICAL STUDY: REPORTEDLY, THE PATIENT HAD A HEART VALVE REPLACEMENT ON (B)(6) 2009 FOR AORTIC STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2009 TO A LONG TERM CARE FACILITY ON VENTILATION. THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 41 DAYS (1.33 MONTHS). CAUSE OF DEATH HAS NOT BEEN PROVIDED. IT HAS NOT BEEN ASSESSED IF THE DEATH WAS DEVICE RELATED. IT WAS REPORTED THAT THE HOSPITAL LEARNED OF THE PATIENT'S PASSING FROM THE (B)(6) RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700TFX R-09E1073

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death LIPITOR 10 MG DAILY| ATROVENT NEBS Q 6H| CALCIUM CARBONATE/VIT D 500 MG TID| PRN SEROQUEL 25 MG AT BEDTIME| SENNA 5 ML PER PEG AT BEDTIME| LOPRESSOR 12.5 MG 12 PER PEG BID| ZAROXOLYN 2.5 MG DAILY| HEPARIN SUBQ 5000 UNITS BID| NEXIUM 40 MG DAILY| PRN PERCOCET 1 TAB Q 4H FOR PAIN LEVEL 4-6| COLACE 100MG TID| FUROSEMIDE 4 MG BID| NYSTATIN TOPICAL POWEDER 1 APPLICATION TOP ROUTINE| INSULIN DRIP 1 UNIT/H| XOPENEX NEBS Q 6H