BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1953414 · Received January 9, 2011

    Report

    Report Number
    2015691-2011-14649
    Event Type
    Injury
    Date Received
    January 9, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE SALES REP MET WITH THE SURGEON AFTER THE CASE AND HAS CONFIRMED THAT THERE IS NO HISTORY OF ENDOCARDITIS. NURSE SAID THAT, WHEN THEY FIRST IMPLANTED THE DEVICE, THE PATIENT WAS REALLY SICK. THE MEANING OF THIS STATEMENT WAS NOT SPECIFIC. HOWEVER, SHE SAID THAT THIS CAN BE VERIFIED IN THE PATIENT HISTORY. THE HOSPITAL DID NOT WANT TO RELEASE THIS VALVE AS IT HAD TO GO TO THEIR RISK MANAGEMENT FIRST. WE CONTACTED THE HOSPITAL RISK MANAGEMENT FOR RETURN OF THE DEVICE AND ADDITIONAL INFORMATION. WE WERE ABLE TO GET THE DEVICE BACK FOR EVALUATION ON (B)(6) 2011. HOWEVER, NO REPORTS HAVE BEEN PROVIDED. INVESTIGATION IS ON-GOING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    THE SALES REP RECEIVED A REPORT FROM THE HOSPITAL OF A DEVICE EXPLANT. THE CALCULATED IMPLANT DURATION IS APPROXIMATELY 4 YEARS 8 MONTHS (55.63 MONTHS). THE EVENT WAS DESCRIBED AS FOLLOWS: THE PATIENT PRESENTED AND THE [SURGEON] THOUGHT THE LEAFLETS WERE CALCIFIED OR FROZEN. THERE WAS A GROWTH ON THE LEAFLETS SEEN ON ECHO. THE LEAFLETS WERE FROZEN AND NOT MOVING. THE SURGEON SAID HE PEELED THE GROWTH OFF THE LEAFLET AND THEN THE LEAFLET WAS FREE TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 5G1392

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R