BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING

    MDR report key: 3090378 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19969
    Event Type
    Death
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE ARTICLE CONCLUSION READS: IN SELECTED PATIENTS WITH CHRONIC ISCHEMIC LV DYSFUNCTION, MITRAL ANNULOPLASTY WITH THE IMR ETLOGIX RING, COMBINED WITH COMPLETE MYOCARDIAL REVASCULARIZATION, RESTORED THE MITRAL APPARATUS GEOMETRY AND COMPETENCE. AN EMAIL HAS BEEN SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION AND CLARIFICATION OF INFORMATION WITHIN THE ARTICLE. NO RESPONSE HAS BEEN RECEIVED TO DATE. NO PATIENT IDENTIFIER INFORMATION WAS PROVIDED IN THE ARTICLE. NO DEVICE IS INDICATED AS AVAILABLE FOR RETURN. AFTER REVIEW OF THE ARTICLE, IT WAS DETERMINED THAT ONE PATIENT REPORTEDLY EXPIRED SUDDENLY DUE TO UNKNOWN CAUSES. DATE OF DEATH REMAINS UNKNOWN. ALTHOUGH THIS MOST LIKELY WAS NOT DUE TO A MALFUNCTION OR DEFICIENCY OF THE DEVICE, IT HAS NOT BEEN DISASSOCIATED BY THE HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN ARTICLE PUBLISHED IN THE JOURNAL OF HEART VALVE DISEASE, "MITRAL ANNULOPLASTY WITH IMR ETLOGIX RING FOR ISCHEMIC MITRAL REGURGITATION AND LEFT VENTRICULAR DYSFUNCTION"; GIUSEPPE GATTI, BRUNO PINAMONTI, LUCA DELL ANGELA, FRANCESCO ANTONINI-CANTERIN, BERNARDO BENUSSI, GIANFRANCO SINAGRA, ANIELLO PAPPALARDO. ABSTRACT: CHRONIC ISCHEMIC MITRAL REGURGITATION (IMR) IS ASSOCIATED WITH ASYMMETRIC MITRAL LEAFLET TETHERING AND ANNULAR DILATION. THE CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIXR ANNULOPLASTY RING IS DESIGNED SPECIFICALLY TO TREAT THESE ASYMMETRIC PATHOLOGICAL CHANGES. IN THE PRESENT STUDY, THE RESULTS OF MITRAL ANNULOPLASTY WITH THIS RING IN A SELECTED SUBSET OF PATIENTS WITH SIGNIFICANT IMR AND LEFT VENTRICULAR (LV) DYSFUNCTION WERE ANALYZED. RESULTS: ALL PATIENTS UNDERWENT COMPLETE MYOCARDIAL REVASCULARIZATION. ONE (3%) IN-HOSPITAL (NON-CARDIAC) DEATH OCCURRED. DURING A MEAN FOLLOW UP OF 3.4 +/-1.5 YEARS ((B)(6)), ONE EARLY MITRAL REPLACEMENT WAS REQUIRED (DUE TO ENDOCARDITIS), AND THERE WERE TWO CARDIAC DEATHS AND THREE NON-CARDIAC DEATHS. THE FOUR-YEAR ACTUARIAL SURVIVAL AND FREEDOM FROM HEART FAILURE HOSPITAL READMISSION WERE 82% AND 75%, RESPECTIVELY. HEART FAILURE SYMPTOMS WERE IMPROVED (P = 0.001), AND IMR WAS WELL CONTROLLED WITHIN GRADE 1+ (P <0.0001) FOR THE 24 REMAINING PATIENTS. THE MAD, TA AND TH WERE EACH DECREASED IN ALL THREE ECHOCARDIOGRAPHIC VIEWS (P =0.0006). THE MAD REDUCTION WAS GREATER IN THE LONG-AXIS VIEW THAN IN THE FOUR-CHAMBER (56% VERSUS 49%, P = 0.002) AND TWO-CHAMBER (56% VERSUS 43%, P = 0.0003) VIEWS. CONCLUSION: IN SELECTED PATIENTS WITH CHRONIC ISCHEMIC LV DYSFUNCTION, MITRAL ANNULOPLASTY WITH THE IMR ETLOGIX RING, COMBINED WITH COMPLETE MYOCARDIAL REVASCULARIZATION, RESTORED THE MITRAL APPARATUS GEOMETRY AND COMPETENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192279 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R