BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1571908 · Received January 7, 2010

    Report

    Report Number
    2015691-2010-12444
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    December 9, 2009
    Report Date
    December 9, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO THE INFECTION. TYPE AND SOURCE OF INFECTION WAS NOT DISCLOSED. THIS WAS DETERMINED REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE DHR REVIEW HAS BEEN STARTED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    REPORTEDLY, DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 67.67 MONTHS DUE TO ENDOCARDITIS CAUSING MITRAL REGURGITATION AND STRUCTURE VALVE DETERIORATION. THE DEVICE WAS IMPLANTED TO CORRECT MITRAL REGURGITATION AND STRUCTURAL VALVULAR DETERIORATION. THIS PATIENT HAD AN OMC (OPEN MITRAL COMMISSUROTOMY) IN 1975. RE-OMC WAS PERFORMED IN 1989 AND MVR WITH ANOTHER DEVICE AND TAP BY DEVEGA METHOD WERE PERFORMED. IN 2004, RE-MVR WAS PERFORMED DUE TO THE STRUCTURAL VALVULAR DETERIORATION OF BOTH DEVICES WERE IMPLANTED AS A REPLACEMENT. IN 2008, LDH VALUE WAS INCREASED. IN 2009, PATIENT HAD ANEMIA (HB 8.1). PROLAPSE WAS OBSERVED DURING THE ECHOCARDIOGRAPHY, AND IT WAS DIAGNOSED AS A MITRAL REGURGITATION. THREE MONTHS LATER, THE DEVICE WAS EXPLANTED DUE TO THE MITRAL REGURGITATION AND STRUCTURAL VALVULAR DETERIORATION. IT IS UNKNOWN WHAT VALVE WAS IMPLANTED AS A REPLACEMENT. IT SEEMED IT WAS A PROLAPSE OF ONE LEAFLET. CUSTOMER DOES NOT THINK THIS EXPLANT WAS CAUSED BY THE DEFECT OF THE PRODUCT, BUT SINCE PREVIOUS SECOND VALVE WAS IMPLANTED FOR 15 YEARS, HE FELT IT WAS EARLY TO BE EXPLANTED IN 5 YEARS.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, CROSSING DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 85% STENOSED, 23MM X 2.75MM, ECCENTRIC, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY (RCA) ARTERY. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED CORONARY BALLOON. DURING INSERTION, THE PHYSICIAN ATTEMPTED TO ADVANCE A 2.75 X 24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) HOWEVER, ENCOUNTERED SIGNIFICANT RESISTANCE AND COULD NOT CROSS THE LESION. THE PHYSICIAN SUCCESSFULLY REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CURRENT CONDITION IS REPORTED AS STABLE. HOWEVER, ANALYSIS OF THE 2.75 X 24MM TAXUS LIBERTE SDS REVEALED A MIDSHAFT AND HYPOTUBE BREAK ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900 03J051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention