BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4086405 · Received September 12, 2014

    Report

    Report Number
    2015691-2014-02140
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: THE MEAN AGE OF ALL 251 PATIENTS WAS 70.5 +/- 10.2 YEARS. THEREFORE, USING THE MEAN AGE OF 70. DEVICE NOT RETURNED. ARTICLE: ¿RIGOROUS PATIENT-PROSTHESIS MATCHING OF PERIMOUNT MAGNA AORTIC BIOPROSTHESIS¿ PUBLISHED ONLINE BY ASIAN CARDIOVASCULAR AND THORACIC ANNALS. DOI: 10.1177/0218492314543654. REPORTEDLY, THERE WERE TWO (2) INFECTIVE ENDOCARDITIS (IE) CASES OUT OF 251 AORTIC VALVE REPLACEMENT CASES WITH AN EDWARDS PERICARDIAL BIOPROSTHESIS. THE DEVICES WERE NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE THERE WAS NO INDICATION THAT THEY WERE EXPLANTED. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. PROSTHETIC VALVE ENDOCARDITIS, WITH OR WITHOUT VEGETATION, IS A SERIOUS COMPLICATION OF CARDIAC VALVE REPLACEMENT AND VALVE REPAIR SURGERIES. IN EARLY CASES OF PROSTHETIC VALVE ENDOCARDITIS, SUBSEQUENT INFECTIONS ARE ALMOST UNIVERSALLY RELATED TO CONTAMINATION AT THE TIME OF SURGERY. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ARTICLE: ¿RIGOROUS PATIENT-PROSTHESIS MATCHING OF PERIMOUNT MAGNA AORTIC BIOPROSTHESIS¿ PUBLISHED ONLINE BY ASIAN CARDIOVASCULAR AND THORACIC ANNALS. DOI: 10.1177/0218492314543654. ABSTRACT: BACKGROUND: SEVERE PATIENT-PROSTHESIS MISMATCH, DEFINED AS EFFECTIVE ORIFICE AREA INDEX LESS THAN OR EQUAL TO 0.65 CM2 M-2, HAS DEMONSTRATED POOR LONG-TERM SURVIVAL AFTER AORTIC VALVE REPLACEMENT. REPORTED RATES OF SEVERE MISMATCH INVOLVING THE PERIMOUNT MAGNA AORTIC BIOPROSTHESIS RANGE FROM 4% TO 20% IN PATIENTS WITH A SMALL ANNULUS. METHODS: BETWEEN JUNE 2008 AND AUGUST 2011, 251 PATIENTS (MEAN AGE 70.5 +/- 10.2 YEARS; MEAN BODY SURFACE AREA 1.55 +/- 0.19 M2) UNDERWENT AORTIC VALVE REPLACEMENT WITH A PERIMOUNT MAGNA BIOPROSTHESIS, WITH OR WITHOUT CONCOMITANT PROCEDURES. WE PERFORMED OUR PROCEDURE WITH RIGOROUS PATIENT-PROSTHESIS MATCHING TO IMPLANT A VALVE APPROPRIATELY SIZED TO EACH PATIENT, AND CARRIED OUT ANNULAR ENLARGEMENT WHEN A 19-MM VALVE DID NOT FIT. THE BIOPROSTHETIC PERFORMANCE WAS EVALUATED BY TRANSTHORACIC ECHOCARDIOGRAPHY PREDISCHARGE AND AT 1 AND 2 YEARS AFTER SURGERY. RESULTS: OVERALL HOSPITAL MORTALITY WAS 1.6%. ONLY 5 (2.0%) PATIENTS REQUIRED ANNULAR ENLARGEMENT. THE MEAN FOLLOW-UP PERIOD WAS 19.1 +/- 10.7 MONTHS WITH A 98.4% COMPLETION RATE. PREDISCHARGE DATA SHOWED A MEAN EFFECTIVE ORIFICE AREA INDEX OF 1.21 +/- 0.20 CM2 M-2. MODERATE MISMATCH, DEFINED AS EFFECTIVE ORIFICE AREA INDEX LESS THAN OR EQUAL TO 0.85 CM2 M-2, DEVELOPED IN 4 (1.6%) PATIENTS. NONE DEVELOPED SEVERE MISMATCH. DATA AT 1 AND 2 YEARS SHOWED ONLY TWO CASES OF MODERATE MISMATCH; NEITHER WAS SEVERE. CONCLUSIONS: RIGOROUS PATIENT-PROSTHESIS MATCHING MAXIMIZED THE PERFORMANCE OF THE PERIMOUNT MAGNA, AND NO SEVERE MISMATCH RESULTED IN THIS JAPANESE POPULATION OF AORTIC VALVE REPLACEMENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566276 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R