BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801142 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01072
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 1, 2010
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HIGH GRADIENTS. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES REGURGITATION AND HIGH GRADIENTS. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING RE-OPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    DEVICE: LEAFLET THICKENED. ADDITIONAL MANUFACTURER NARRATIVE: NEW INFORMATION RECEIVED INDICATES THAT THE MOTION OF THE PROSTHETIC MITRAL VALVE IS RESTRICTED WITH THICKENING LEAFLET AND MODERATE MITRAL REGURGITATION. THIS EVENT IS CONSIDERED A REPORTABLE MALFUNCTION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION RECEIVED INDICATES MITRAL REGURGITATION WAS MODERATE. THIS EVENT IS NOT CONSIDERED A REPORTABLE MALFUNCTION, NOR A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AT A LATER DATE INDICATES THE (B)(4) REGURGITATION GRADING SYSTEM IS BASED ON A SCALE OF 1 TO 6, TRIVIAL THROUGH SEVERE. IN THIS CASE, MITRAL REGURGITATION OF +4 IS CONSIDERED MODERATE.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED MODERATE MITRAL REGURGITATION AT SIX (6) MONTHS AFTER IMPLANT. AT THREE (3) YEARS, FOUR (4) MONTHS MITRAL REGURGITATION PROGRESSED TO SEVERE, WHILE MITRAL GRADIENT WAS 11MMHG (MEAN) AND 21MMHG (PEAK), MITRAL GRADIENT WAS ABOVE EXPECTED RANGE. DEVICE REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AT A LATER DATE INDICATES THAT THE MOTION OF THE PROSTHETIC MITRAL VALVE IS RESTRICTED WITH THICKENING LEAFLET AND MODERATE MITRAL REGURGITATION. PATIENT'S STATUS IS OKAY AND DOES NOT REQUIRE INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON A LATER DATE THAT THE PATIENT WENT FOR A FOLLOW UP ON 05/27/2015. IT WAS NOTED THAT PATIENT HAD INCREASING SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. NO INTERVENTION WAS INDICATED OR REQUIRED. PATIENT'S MEDICATION WAS ADJUSTED AND PATIENT IS TO BE FOLLOWED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278936 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR