BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4183122 · Received October 17, 2014

    Report

    Report Number
    2015691-2014-02454
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, ALL THREE LEAFLETS HAD VEGETATION IN THE CUSP AREAS ON THE OUTFLOW AND INFLOW ASPECT. OBSERVATIONS ARE CONSISTENT WITH INFECTION AS DESCRIBED IN CUSTOMER REPORT. HOST TISSUE WAS MINIMAL ON THE TISSUE OUTFLOW AND ENCROACHED ONTO THE TISSUE BY A GREATEST DISTANCE OF 5MM. HOST TISSUE WAS MINIMAL TO MODERATE AT THE STENT OUTFLOW. INCIDENTAL FINDINGS: THE X-RAY DEMONSTRATED NO VISIBLE CALCIFICATION, COMMISSURE 2 WIREFORM DISTORTED. THESE DAMAGES ARE MOST LIKELY DUE TO EXPLANT OR IMPLANT. ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED ENDOCARDITIS WAS CONFIRMED BY DEVICE EVALUATION. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO MANUFACTURER. WITHOUT RETURN OF THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION, THE REPORTED EXPLANT CANNOT BE INVESTIGATED AND A ROOT CAUSE CANNOT BE DETERMINED. NO CAPA IS APPLICABLE; HOWEVER, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, EDWARDS RECEIVED INFORMATION THAT A 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY FIVE (5) MONTHS AND FIFTEEN (15) DAYS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A ANOTHER 21MM BIOPROSTHETIC. THERE WERE NO COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HCP INDICATES VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. PATIENT WAS NOTED TO HAVE SIGNIFICANT ENDOCARDITIS, ABCESS AND VEGETATION. BOTH THE THE AORTIC AND TRICUSPID VALVE WERE AFFECTED BY ENDOCARDITIS, BOTH VALVES WERE REPLACED WITH NO NOTED DYSFUNCTIONS. PATIENT EXPIRED ON POST-OP DAY 1 DUE TO RECURRENT VTACH, ACIDOSIS AND PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661165 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 3999413

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R