BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1953268 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14634
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    October 6, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. FURTHERMORE, THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED AT THE TIME OF DEATH; (B)(4).

    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, IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY, THE PATIENT HAD A FLEXIBLE FIBEROPTIC BRONCHOSCOPY AND A RIGHT VIDEO-ASSISTED THORACIC SURGERY, TOTAL PULMONARY DECORTICATION AND PLEURAL BIOPSIES PERFORMED FOR RECURRENT RIGHT-SIDED PLEURAL EFFUSIONS. THE PROCEDURES WENT WELL WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. NO OTHER DETAILS WERE PROVIDED. FURTHERMORE, THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-09E1231

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death