BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2110792 · Received June 1, 2011

    Report

    Report Number
    2015691-2011-15667
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    January 7, 2011
    Report Date
    May 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE SURGEON COMMENTED THAT THE EXPLANT OF THIS DEVICE WAS DUE TO THE PROFILE OF THE DEVICE BEING TOO HIGH AT THE LEFT CORONARY OSTIUM. PARTIAL OR TOTAL OCCLUSION OF THE CORONARY OSTIA IS A RECOGNIZED COMPLICATION OF AN AORTIC VALVE REPLACEMENT. IT IS TYPICALLY THE RESULT OF A TECHNICAL ERROR DURING VALVE IMPLANT AND NOT RELATED TO A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER THROUGH SALES INDICATING THE VALVE WAS EXPLANTED AT IMPLANT AND REPLACED BY THE SAME SIZE BUT DIFFERENT MODEL VALVE. THE REASON FOR EXPLANT WAS DUE TO THE PROFILE OF THE VALVE BEING A LITTLE HIGH AT THE LEFT CORONARY OSTIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 10J202

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R