BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2490457 · Received March 13, 2012

    Report

    Report Number
    2015691-2012-17074
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED DUE TO PATIENT'S HISTORY (B)(4). MULTIPLE ATTEMPTS WITH THE HEALTHCARE PROVIDER HAVE BEEN MADE TO OBTAIN THE OPERATIVE REPORT, PATIENT HISTORY, AND ADDITIONAL DETAILS; HOWEVER THE HEALTHCARE PROVIDER HAS STATED THAT THEY CANNOT RELEASE ANY PATIENT RECORDS. STENOSIS OF AN IMPLANTED VALVE CAUSES THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE AND CAN BE, DEPENDING ON THE SEVERITY, AN INDICATION FOR VALVE REPLACEMENT. WITHOUT DEVICE RETURN AND EVALUATION THE REPORTED CALCIFICATION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE A QUALITY DEFICIENCY OF THE DEVICE DURING MANUFACTURING THAT MAY HAVE CAUSED OR CONTRIBUTED TO ITS EXPLANT.

    Additional Manufacturer Narrative · 1

    PER THE RECEIVED OPERATIVE REPORT, IT IS LIKELY THAT PATIENT'S CONDITION AND COMORBIDITIES MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6900-29MM MITRAL BIOPROSTHESIS WAS EXPLANTED AFTER A DURATION OF 100 MONTHS DUE TO, "MITRAL STENOSIS DUE TO CALCIFIED LEAFLETS. PATIENT IS (B)(6); AND (B)(6)." ALTHOUGH EFFORTS HAVE BEEN MADE TO OBTAIN THE OPERATIVE REPORT, IT HAS NOT BEEN RELEASED BY THE HEALTHCARE PROVIDER AT THIS TIME.

    Description of Event or Problem · 1

    THE RECEIVED OPERATIVE REPORT CONFIRMS PATIENT WAS DIAGNOSED WITH PROSTHETIC MITRAL VALVE STENOSIS. PATIENT'S SECONDARY DIAGNOSES INDICATE: (B)(6), STAGE III CHRONIC KIDNEY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, PROSTATE CANCER, GERD, THROMBOCYTOPENIA, PULMONARY HYPERTENSION, REMOTE SUBSTANCE ABUSE, ACUTE BLOOD LOSS ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES LLC 6900P 3H1343

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R