BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 5470481 · Received March 1, 2016

    Report

    Report Number
    2015691-2016-00610
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND DEVICE RETURN WERE UNSUCCESSFUL. HEALTHCARE PROVIDER REPORTED THAT IF THE DEVICE WAS SENT TO PATHOLOGY IT WOULD HAVE BEEN DISCARDED LONG AGO.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE ARE IN PROCESS. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROCESS. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. BASED ON THE INFORMATION PROVIDED THE CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ARTICLE: "THE CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL VALVE BIOPROSTHESIS: INTERMEDIATE TERM - EFFICACY AND DURABILITY" PUBLISHED IN JOURNAL OF CARDIOTHORACIC SURGERY. DOI 10.1186/S13019-016-0412-4. ABSTRACT: BACKGROUND: THE CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL VALVE BIOPROSTHESIS (EDWARDS LIFESCIENCES, (B)(4)) IS A LOW-PROFILE VERSION OF THE EARLIER PERIMOUNT VALVE THAT USES THE THERMAFIX PROCESS FOR ENHANCED CALCIUM REMOVAL. THE MAGNA VALVE HAS BEEN IN USE SINCE 2008, YET NO PUBLICATION, UNTIL NOW, HAS VERIFIED ITS INTERMEDIATE-TERM SAFETY AND EFFICACY. METHODS: FROM 2008 THROUGH 2011 (OUR 4-YEAR STUDY PERIOD), 70 MAGNA VALVES WERE IMPLANTED IN THE MITRAL POSITION AT A SINGLE INSTITUTION (THE CLEVELAND CLINIC). ECHOCARDIOGRAMS WERE PROSPECTIVELY INTERPRETED. FOR THIS STUDY, WE REVIEWED PATIENTS CHARTS; ENDPOINTS INCLUDED HEMODYNAMIC MEASUREMENTS, IN-HOSPITAL MORBIDITY AND MORTALITY, VALVE-RELATED EVENTS, RESOURCE UTILIZATION, AND 5-YEAR SURVIVAL RATES. RESULTS: THE MEAN PATIENT AGE WAS 68 YEARS; 43 % OF THE PATIENTS HAD NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV DISEASE, AND 51.4 % HAD MODERATELY SEVERE, OR WORSE, MITRAL REGURGITATION (MR). FOR 43 % OF THE PATIENTS, THE MAGNA VALVE IMPLANTATION WAS A REOPERATION. FOR 83 %, THE MAGNA VALVE IMPLANTATION ALSO INCLUDED A CONCOMITANT CARDIAC PROCEDURE. THE MEDIAN SURVIVAL RATE WAS 4.7 YEARS AND 90 % OF PATIENTS WERE FREE FROM SIGNIFICANT STRUCTURAL VALVE DEGENERATION AT 5 YEARS. PREOPERATIVE ATRIAL FIBRILLATION, ISCHEMIC MR, INTRAAORTIC BALLOON PUMP PLACEMENT, CARDIOGENIC SHOCK, CARDIAC ARREST, AND RENAL FAILURE WERE ASSOCIATED WITH INCREASED MORTALITY. RIGHT VENTRICULAR SYSTOLIC PRESSURE DECREASED FROM 50 MMHG PREOPERATIVELY TO 40 MMHG POSTOPERATIVELY, ACCORDING TO OUR MATCHED-PAIR ANALYSIS (P = 0.003). PER THEIR FINAL ECHOCARDIOGRAM DURING OUR STUDY PERIOD, 98 % OF SURVIVING PATIENTS HAD TRIVIAL OR NO MR, ONE PATIENT HAD MILD MR, AND ONE PATIENT HAD SEVERE MR. CONCLUSIONS: OUR 5-YEAR EXPERIENCE INDICATES THAT THE MAGNA VALVE OFFERS EXCELLENT INTERMEDIATE-TERM DURABILITY AND SUBSTANTIAL ECHOCARDIOGRAPHIC IMPROVEMENT; ITS LOW-PROFILE DESIGN MAKE IT IDEAL FOR REOPERATIONS AND FOR CONCOMITANT CARDIAC PROCEDURES, INCLUDING VALVE REPLACEMENT. IN THIS CASE, IT WAS LEARNED THAT A PATIENT UNDERWENT REOPERATION AFTER AN IMPLANT DURATION OF SIX (6) MONTHS DUE TO STRUCTURAL VALVE DETERIORATION (SVD), CALCIFICATION, AND MILD REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127660 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R