BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1841809 · Received September 22, 2010

    Report

    Report Number
    2015691-2010-14095
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = STRUT AT THE RIGHT NON COMMISSURE WAS BENT INWARD ABOUT 30 DEGREES.DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, THE VALVE TISSUE WAS CUT OFF. APPROXIMATELY 2-3MM OF TISSUE REMAINS INTACT ALONG THE ATTACHMENT. THREE SECTIONS OF TISSUE ALSO REMAIN ATTACHED AT THE COMMISSURES; EACH MEASURE TO APPROXIMATELY 3MM BY 7MM. THE X-RAY DEMONSTRATES STENT DISTORTION AND WIREFORM TO BAND SEPARATION. COMMISSURE 3 APPEARS TO BE BENT TOWARD THE CENTER OF THE VALVE, WHICH IS EVIDENT IN THE X-RAY. THE CURRENT POSITION OF COMMISSURE 3 IS MOST LIKELY DUE TO EXTERNAL FORCE ONTO THE COMMISSURE MAY BE AT IMPLANT OR EXPLANT. HOWEVER, DUE TO THE CURRENT CONDITION OF THE VALVE RECEIVED, IT IS NOT POSSIBLE TO RELATE THE POSITION AND THE FUNCTIONALITY OF THE LEAFLETS IN RELATION TO THE STENT. NOT ABLE TO EVALUATE DUE TO THE CURRENT CONDITION OF THE VALVE. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE ALONG WITH A COPY OF THE PATHOLOGY REPORT WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 37.50 MONTHS. ON (B)(6)2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY AND WHAT APPEARED TO BE A MASS EFFECT IN THE NONCORONARY SINUS OF THE AORTIC PROSTHESIS. PER THE OPERATIVE NOTE OF (B)(6)2010, "THE AORTIC PROSTHESIS WAS INTACT AND WELL SEATED. NO MASS WAS SEEN, BUT THE STRUT AT THE RIGHT-NON COMMISSURE WAS BENT INWARD ABOUT 30 DEGREES, AND MAY HAVE ACCOUNTED FOR THE ECHO FINDING." THEREFORE, THE VALVE WAS REPLACED WITH ANOTHER BIOPROSTHESIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 R-06M0805

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention