BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 5592169 · Received April 20, 2016

    Report

    Report Number
    2015691-2016-01299
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 1, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 RECEIVED THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND, CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS, MODEL# 3300TFX, PMA# P860057/S042. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROCESS. WITHOUT ADDITIONAL INFORMATION OR RETURN OF THE DEVICE THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. 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

    A 23MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED BY TF APPROACH AND ONLY A MILD PVL REMAINED. THE PATIENT WAS A LADY (B)(6) ENROLLED IN A CLINICAL TRIAL STUDY.

    Description of Event or Problem · 1

    THROUGH FOLLOW UP EDWARDS RECEIVED INFORMATION THAT A 23MM VALVE IS SHOWING CALCIFICATION LEADING TO STENOSIS (MEAN/MAX GRADIENT 57/84 MMHG - HEART RATE 65BPM - AO 0.6CM2 ) AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FIVE (5) MONTHS. THE PATIENT IS A LADY OF (B)(6) ENROLLED IN THE CLINICAL TRIAL STUDY. AS REPORTED BY THE CLINICAL TRIAL TEAM, DURING THE STUDY NO SVD WAS REPORTED FOR THIS CASE. ECHO PERFORMED AT 4 MONTHS SHOWED NORMAL STUDY VALVE. CALCIFICATION OF THE VALVE WAS DETECTED ON ECHO PERFORMED 5 YEARS AND 5 MONTHS AFTER THE IMPLANT.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A 19MM AORTIC VALVE IS SHOWING STRUCTURAL VALVE DETERIORATION. SURGEON IS CONSIDERING PATIENT TO UNDERGO VALVE-IN-VALVE INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248677 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R