BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3962114 · Received July 28, 2014

    Report

    Report Number
    2015691-2014-01713
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 30, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO EDWARDS FOR EVALUATION AND THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE HEALTHCARE PROVIDER. THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    LATE ENDOCARDITIS OCCURS DUE TO THE IMPLANT BEING SEEDED FROM AN INFECTION OR MICROBIAL CONTAMINATION FROM ELSEWHERE IN THE BODY. DENTAL, GENITOURINARY, AND GASTROINTESTINAL MANIPULATION ARE KNOWN CAUSES OF TRANSIENT BACTEREMIA, WHICH CAN PLACE A PATIENT AT RISK FOR PROSTHETIC ENDOCARDITIS. THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS, THEREFORE THE CLINICAL OBSERVATION CANNOT BE CONFIRMED OR EVALUATED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    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 MITRAL BIOPROSTHETIC VALVE, IMPLANTED APPROXIMATELY SIX (6) YEARS AND NINE (9) MONTHS, WAS EXPLANTED AND REPLACED WITH ANOTHER EDWARDS PERICARDIAL MITRAL VALVE. THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    RESPONSE FROM THE HEALTHCARE PROVIDER WAS RECEIVED INDICATING THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION BY THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437900 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R