BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 72856 · Received February 26, 1997

    Report

    Report Number
    6000002-1997-00163
    Event Type
    Injury
    Date Received
    February 26, 1997
    Date of Event
    December 4, 1996
    Report Date
    January 27, 1997
    Manufacturer
    EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3: EXAMINATION OF VALVE IN CO'S LAB REVEALED HOST TISSUE OVERGROWTH HAD FUSED ATTACHMENT SITE BETWEEN TWO CUSPS AND ENCROACHED ONTO EACH LEAFLET WHICH RESULTED IN WAVY FREE MARGINS, INCOMPLETE COAPTATION, STENOSIS OF EFFECTIVE ORIFICE AREA AND LEAFLET DISRUPTION. CALCIFICATION WAS NOTED WITHIN BELLY OF EACH CUSP WHICH CONTRIBUTED TO STENOSIS OF VALVE. X-RAY ANLAYSIS REVEALED CALCIFICATION WITHIN BELLY OF EACH CUSP. STENT DISTORTION WAS ALSO NOTED WHICH APPEARED ARTIFACTUAL EXPLANT. PRIMARY CAUSE FOR DYSFUNCTION OF THIS VALVE WAS DETERMINED TO BE DUE TO HOST TISSUE OVERGROWTH. THESE FINDINGS WOULD ACCOUNT FOR SYPMTOMS NOTED CLINICALLY. H6: 86= X-RAY ANALYSIS.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS "DYSFUNCTION", DEGENERATION & REGURGITATION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Implant REPLACEMENT HEART VALVE LWR EDWARDS CVS DIV. BAXTER HEALTHCARE CORP. 6900 4G889

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention
    2