BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2191731 · Received August 4, 2011

    Report

    Report Number
    2015691-2011-15984
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO INCONSISTENCIES DETECTED IN THE VALVE RECEIVED AS THE LEAFLETS ARE INTACT AND FLEXIBLE. NO INCONSISTENCIES DETECTED IN THE X-RAY, AS THE WIREFORM IS INTACT. THE VALVE WAS SENT TO RD FOR FUNCTIONAL TESTING. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CONCLUSION: RESEARCH AND DEVELOPMENT COMPLETED THE FUNCTIONAL TEST AND CONCLUDED WITH THE FOLLOWING: "THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO REGURGITATION WITH A "MILD TO HIGH VELOCITY CENTRAL JET BEING REGURGITATED THROUGH THE VALVE", WHICH COULD NOT BE REPRODUCED BY EDWARDS' STANDARDIZED IN VITRO TESTING. NO ECHOCARDIOGRAPHY WAS PROVIDED, THUS THE BEHAVIOR OF THE VALVE AND THE LEAKAGE OBSERVED IN VIVO CANNOT BE CONFIRMED. EDWARDS' STANDARDIZED IN VITRO TESTING DEMONSTRATES THAT THE FUNCTIONALITY OF THE VALVE IS ACCEPTABLE PER (B)(4). THE AS-RECEIVED VALVE SHOWED A 10.7% TOTAL REGURGITANT FRACTION (TRF). THIS APPEARS TO BE LARGELY THROUGH A NON-CENTRAL ORIGIN BECAUSE SUBSEQUENT RE-TESTING OF THE VALVE WITH THE SEWING RING SEALED SHOWS THAT THE TRF WAS REDUCED TO 3.5%. THIS VALUE IS MORE THAN FOUR TIMES LOWER THAN 15% ALLOWANCE PER (B)(4) FOR THIS SIZE OF VALVE."

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE TO BE RETURNED. NOT YET RECEIVED. ADDITIONAL MANUFACTURER NARRATIVE: THE SALES REP LEARNED THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER THAT THE REQUESTED ECHOCARDIOGRAPHY AND OPERATIVE REPORT ARE NOT AVAILABLE DUE TO PATIENT PRIVACY LAWS. NO PATIENT INFORMATION IS FORTHCOMING. THE DEVICE IS TO BE RETURNED FOR EVALUATION. THE DHR REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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. WITHOUT ADDITIONAL EVENT INFORMATION OR RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTEDLY IMPLANTED A 25MM VALVE AND WHEN CARRYING OUT AN ECHO, AFTER COMING OFF BYPASS, THEY IDENTIFIED A MILD TO HIGH VELOCITY CENTRAL JET BEING REGURGITATED THROUGH THE VALVE. THE SURGEON WENT BACK ON BYPASS, REPLACED THE DEVICE WITH ANOTHER 25MM VALVE AND CARRIED OUT ANOTHER ECHO AFTER COMING OFF BYPASS. ALTHOUGH THERE WAS STILL A CENTRAL JET REGURGITATING THROUGH THE VALVE, IT WAS LESS THAN THE PREVIOUS VALVE AND CLASSED AS MILD. AT (B)(6) 2011, THE PATIENT IS STILL IN HOSPITAL WITH NO ADVERSE PROBLEMS BUT THE SURGEON IS CONCERNED ABOUT THE REGURGITATION THROUGH THE CENTRE OF THE VALVE. HE USUALLY USES A SIZE 23MM AND HAS NOT SEEN AS HIGH A REGURGITANT VELOCITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-11D1505

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R