BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3072780 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19885
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCHARGE LETTER DATED 03/27/2013 WAS TRANSLATED AND PROVIDED ON (B)(4) 2013. DISCHARGE LETTER INDICATED "POST-OPERATIVE COURSE: NORMAL, NO COMPLICATIONS, DISCHARGED FROM CARDIAC SURGERY ICU TO 2ND GPO." CLINICAL CONDITION ON DISCHARGE: APYREXIAL, MOBILISED WELL, GOOD BILATERAL PULMONARY VENTILATION, WOUND IN ORDER. ECG ON DISCHARGE: SR 69 BPM.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. PATIENT HISTORY ALSO INCLUDES PULMONARY HYPERTENSION AND TRICUSPID INSUFFICIENCY DETECTED ON ECHO. ECHO AND OPERATIVE REPORTS HAVE BEEN INDICATED AS AVAILABLE, BUT HAVE NOT BEEN PROVIDED FOR EVALUATION. PATIENT STATUS IS NOTED AS "DISCHARGED". THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE CONDITION OF THE DEVICE AT TIME OF PROCEDURE. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE REPORT INDICATES THE DEVICE WAS STENOTIC DUE TO THE HIGH GRADIENT. STENOSIS CAN BE DUE TO MANY FACTORS, DEPENDING ON THE IMPLANT DURATION, AND INCLUDES BUT IS NOT LIMITED TO CALCIFICATION, THROMBOSIS AND PANNUS. HOWEVER, WITHOUT RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT UNDERWENT VALVE-IN-VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS, 11 MONTHS (71.33 MONTHS) DUE TO MITRAL VALVE INSUFFICIENCY. PER THE REPORT RECEIVED, PATIENT PRESENTED REDUCED LEFT VENTRICLE FUNCTION (EF 45%), MITRAL PROSTHESIS DEGENERATION WITH INCREASED GRADIENT (MEAN 16 MMHG, MAX 39 MMHG), VALVE INSUFFICIENCY (2/4+), PULMONARY HYPERTENSION AND TRICUSPID INSUFFICIENCY AT TEE AND TT ANALYSIS. DEVICE NOT TO BE RETURNED AS IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174782 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 06L294

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R