BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 6152666 · Received December 7, 2016

    Report

    Report Number
    2015691-2016-03594
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 15, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PATIENT PROSTHESIS MISMATCH (PPM) IS PRESENT WITH THE EFFECTIVE ORIFICE AREA OF THE INSERTED PROSTHETIC VALVE IS TOO SMALL IN RELATION TO BODY SIZE. ITS MAIN HEMODYNAMIC CONSEQUENCE IS TO GENERATE HIGHER THAN EXPECTED GRADIENTS THROUGH A NORMALLY FUNCTIONING PROSTHETIC VALVE. PPM HAS BEEN SHOWN TO BE ASSOCIATED WITH WORSE HEMODYNAMIC FUNCTION, LESS REGRESSION OF LEFT VENTRICULAR HYPERTROPHY, MOST CARDIAC EVENTS, AND LOWER SURVIVAL. BASED ON THE INFORMATION RECEIVED PATIENT FACTORS LIKELY CONTRIBUTED TO THE EVENT; HOWEVER, THE CAUSE CANNOT BE CONCLUSIVELY DETERMINED. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THROUGH A CLINICAL TRIAL THAT ON ECHO, A 19 MM AORTIC VALVE IMPLANTED THREE (3) YEARS, ONE (1) MONTH, DEMONSTRATED SEVERE AORTIC STENOSIS WITH ACUTE ON CHRONIC DIASTOLIC CONGESTIVE HEART FAILURE. ECHO REVEALED A VALVE AREA OF 0.74 CM2, AND GRADIENT OF 72 MMHG. THE AORTIC VALVE SHOWED MINOR CALCIFICATION. THE PRINCIPLE INVESTIGATOR ATTRIBUTED THIS TO BIOPROSTHETIC VALVE FAILURE RELATED TO MISMATCH. THIS WAS FOUND DURING AN EXTENDED HOSPITALIZATION FOR PNEUMONIA AND ADVANCING INTERSTITIAL PULMONARY FIBROSIS (IPF). THE HOSPITALIZATION WAS DUE TO SYMPTOMS OF AORTIC STENOSIS, BUT IT WAS HARD TO ASSESS IF THE SUBJECT WAS SYMPTOMATIC DUE TO THE IPF SUPERIMPOSED WITH PNEUMONIA. NO EPISODES OF SYNCOPE NOTED. THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH RVR. SHE WAS DISCHARGED TO HOSPICE CARE RELATED TO MULTIPLE COMORBIDITIES AND DECLINING HEALTH STATUS. IT WAS LEARNED THAT THE PATIENT EXPIRED; THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803079 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R