BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 3100878 · Received May 8, 2013

    Report

    Report Number
    2015691-2013-20035
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. CONTACT HAS BEEN MADE WITH THE AUTHOR BY EMAIL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE HEART 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. IN THIS CASE, NO REFERENCE IS MADE TO THE SOURCE OR TYPE OF INFECTION.

    Description of Event or Problem · 1

    INFORMATION WAS LEARNED THROUGH AN ARTICLE PUBLISHED IN THE JOURNAL OF CARDIAC SURGERY DOI: 10.1111/J.1540-8191.2012.01519.X (J CARD SURG 2012;27:560-562). ABSTRACT READS: ENDOCARDITIS AFTER MITRAL VALVE (MV) ANNULOPLASTY IS UNCOMMON. THE RING USED IN MV ANNULOPLASTY IS OFTEN INADEQUATE BECAUSE IT OPPOSES THE GROWTH OF THE MV LEAFLETS AND ANNULUS. WE REPORT A (B)(6) MALE THAT REQUIRED REDO SURGERY FOR PROSTHETIC RING ENDOCARDITIS 40 MONTHS AFTER A PREVIOUS MV ANNULOPLASTY. AFTER THE PREVIOUS RING WAS REMOVED, THE UNDERGROWN POSTERIOR LEAFLET WAS REPAIRED WITH PERICARDIAL AUGMENTATION AND THE POSTERIOR ANNULUS WAS STABILIZED WITH A SUPRA-ANNULAR STRIP TO PRESERVE A FLEXIBLE VALVE ORIFICE AND ALLOW THE ANTERIOR MV ANNULUS AND THE COMMISSURES TO GROW IN RELATION TO BODY SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200790 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4450

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R