BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2884214 · Received December 21, 2012

    Report

    Report Number
    2015691-2012-18930
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = "TRIANGULAR SHAPED PERIPROSTHETIC AREA OF DEHISCENCE IN DIRECT CONTINUITY WITH THE LEFT VENTRICULAR CAVITY". BASED ON THE OPERATIVE REPORT PROVIDED, THE EXPLANT WAS DUE TO MITRAL VALVE PERIPROSTHETIC LEAK WITH SEVERE MITRAL VALVE REGURGITATION. THE MITRAL PROSTHESIS (SUBJECT VALVE) WAS INTACT AND ALL 3 LEAFLETS WERE SUPPLE AND PLIABLE WITHOUT DISTORTION. THE SEWING RING WAS WELL SEATED AND ADHERENT TO THE MITRAL ANNULUS FROM APPROXIMATELY THE MIDPOINT OF THE SUBAORTIC CURTAIN CLOCKWISE AROUND TO NEARLY THE LEVEL OF THE ANTERIOR COMMISSURE. IN THE REGION OF THE ANTERIOR TRIGONE, HOWEVER, IT BECAME EVIDENT THAT THE SEWING RING WAS NEVER APPROXIMATED TO THE ANNULUS NOR THE TRIGONE WITH THE VALVE SUTURES IN THIS REGION HAVING BEEN PLACED ONLY IN THE ADJACENT ATRIAL WALL BEGINNING JUST MEDIAL TO THE ANTERIOR ANGLE OF THE BASE OF THE LEFT ATRIAL APPENDAGE AND CONTINUING AROUND TO APPROXIMATELY THE MIDPOINT OF THE SUBAORTIC CURTAIN. THE VALVE SUTURES AT THIS LEVEL HAD PULLED THROUGH THE ATRIAL TISSUE FOR THE MOST PART RESULTING IN A TRIANGULAR SHAPED PERIPROSTHETIC AREA OF DEHISCENCE IN DIRECT CONTINUITY WITH THE LEFT VENTRICULAR CAVITY AND RESPONSIBLE FOR THE PERIPROSTHETIC REGURGITATION. THERE WAS NO EVIDENCE OF VEGETATIONS OR ANYTHING TO INDICATE PROSTHETIC VALVE ENDOCARDITIS. THE MITRAL ANNULAR TISSUE ITSELF WAS OF GOOD, SOLID QUALITY WITH ONLY MILD CALCIFICATION RESIDUAL IN THE REGION AT THE BASE OF FORMER SEGMENT P1. TEE AFTER SEPARATION FORM CARDIOPULMONARY BYPASS DEMONSTRATED WELL PERSEVERED CONTRACTILITY OF BOTH VENTRICLES ON LOW DOSE INOTROPIC SUPPORT WITH DOBUTAMINE. THE NEW MITRAL VALVE BIOPROSTHESIS APPEARED TO FUNCTION NORMALLY WITH TYPICAL, TRIVIAL CENTRAL REGURGITATION JET AND NO PERIPROSTHETIC LEAK. AORTIC VALVE FUNCTION WAS UNCHANGED AND THERE WERE NO NEW ABNORMALITIES OF THE THORACIC AORTIC. UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. ALTHOUGH THE ROOT CAUSE CANNOT BE INVESTIGATED, PER THE OPERATIVE REPORT, "THE VALVE SUTURES" HAD PULLED THROUGH THE ATRIAL TISSUE FOR THE MOST PART RESULTING IN A TRIANGULAR SHAPED PERIPROSTHETIC AREA OF DEHISCENCE IN DIRECT CONTINUITY WITH THE LEFT VENTRICULAR CAVITY AND RESPONSIBLE FOR THE PERIPROSTHETIC REGURGITATION. DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE VALVE REPAIR IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. LATE DEHISCENCE CAN OCCUR AS A RESULT OF SUCCESSIVE DILATATION OF CARDIAC STRUCTURES THAT RESULT FROM PROGRESSION OF DISEASE. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. TYPICALLY, MILD REGURGITATION IS NOT UNUSUAL AFTER INITIAL VALVE REPLACEMENT, AND IS USUALLY TOLERATED BY PATIENTS. 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. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R