BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1912097 · Received December 1, 2010

    Report

    Report Number
    2015691-2010-14460
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    April 18, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NOTIFICATION WAS RECEIVED IN THE FORM OF A RETURNED PATIENT REGISTRATION CARD WITH THE NOTATION "DECEASED (B)(6) 2010". NO CAUSE OF DEATH WAS NOTED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    IT WAS ALSO INDICATED THAT THE DEVICE REMAINS IMPLANTED. STROKE OR CEREBRAL VASCULAR ACCIDENT (CVA) IS A RELATIVELY COMMON COMPLICATION THAT TYPICALLY OCCURS IN AN OLDER POPULATION. THERE ARE MANY CAUSES, INCLUDING HYPERTENSION, ATRIAL FIBRILLATION, AND EMBOLIZATION FROM A CAROTID ARTERY LESION. ACCORDING TO THE HEALTH CARE PROVIDER, THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IN THIS CASE, A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THE CAUSE OF DEATH AS STROKE. THE PATIENT HAD A HISTORY OF ISCHAEMIC HEART DISEASE. THE SURGEON INDICATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH AND THAT THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE REGISTRY WAS INFORMED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 19 DAYS (0.63 MONTHS) DUE TO UNKNOWN REASONS. NO CAUSE OF DEATH WAS PROVIDED. THERE WAS NO INDICATION GIVEN THAT THE DEATH WAS DUE TO A DEVICE MALFUNCTION OR THAT THE DEVICE WAS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 09K724

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R