BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 4877017 · Received June 29, 2015

    Report

    Report Number
    2015691-2015-01564
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE OR ADDITIONAL INFORMATION ARE IN PROCESS. PER THE ARTICLE, METABOLIC SYNDROME (MS) CAN RESULT IN EARLY BIOPROSTHESIS FAILURE (EBF). "IT IS REPORTED THAT MS IS INDEPENDENTLY ASSOCIATED WITH FASTER BIOPROSTHETIC VALVE DETERIORATION. OBSERVED ACCELERATED BIOPROSTHETIC VALVE CALCIFICATION IN PATIENTS IN PATIENTS WITH END-STAGE RF WHO HAD A HIGH LEVEL OF BLOOD CALCIUM. IT MAY BE THAT MS CAN ACCELERATE BIOPROSTHETIC VALVE CALCIFICATION. MS SHOULD BE CORRECTED AFTER BIOPROSTHETIC VALVE REPLACEMENT IN ORDER TO AVOID EBF." 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. WITHOUT RETURN OF THE DEVICE OR ADDITIONAL INFORMATION THE ROOT CAUSE OF THE REPORTED EVENT 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: "EARLY BIOPROSTHESIS FAILURE: REPORT OF THREE CASES AND LITERATURE REVIEW PUBLISHED BY FORUM MULTIMEDIA PUBLISHING, LLC, DOI: 10.1532/HSF.1242. ABSTRACT - BACKGROUND: WE EXPERIENCED THREE RARE EARLY BIOPROSTHESIS FAILURE (EBF) CASES. IN THIS STUDY, WE ANALYZE THE CAUSES AND DISCUSS THE COPING STRATEGY OF EBF. METHODS: WE REVIEWED ALL CASES OF EBF IN PATIENTS WHO RECEIVED A BIOPROSTHESIS REPLACEMENT IN (B)(6) HOSPITAL BETWEEN (B)(6) 2001 AND (B)(6) 2014, AND REVIEWED RELATED ARTICLES THAT WERE PUBLISHED BETWEEN 1994 AND 2014, SEARCHING FOR KEYWORDS IN PUBMED SUCH AS ¿BIOPROSTHESIS,¿ ¿HEART VALVE PROSTHESIS,¿ ¿EARLY FAILURE,¿ AND ¿BIOPROSTHESIS FAILURE.¿ RESULTS: ONLY THREE CASES WERE FOUND IN (B)(6) HOSPITAL DURING THIS TIME PERIOD. THE REASONS FOR EBF IN THESE 3 CASES WERE: NATIVE VALVE ATTACHMENT, EARLY CALCIFICATION CAUSED BY METABOLIC SYNDROME, AND EARLY VALVE THROMBOSIS. LITERATURE REVIEW IDENTIFIED ADDITIONAL 14 CASES. THE REASONS FOR EBF IN THESE 14 CASES WERE AS FOLLOWS: NATIVE VALVE ATTACHMENT IN 6 CASES; METABOLIC ABNORMALITIES IN 3 CASES; EARLY VALVE THROMBOSIS IN 2 CASES; CHRONIC INFLAMMATION IN 2 CASES; AND IMPROPER OPERATION IN 1 CASE. CONCLUSION: EBF IS A RARE BUT SERIOUS COMPLICATION. THE CAUSE OF EBF IS COMPLEX. APPROPRIATE PREVENTIVE MEASURES SHOULD BE DEVELOPED ACCORDING TO THE CONDITION OF THE PATIENT. THIS REPORT IS FOR A (B)(6) FEMALE PATIENT WHO UNDERWENT RE-DO AORTIC VALVE REPLACEMENT OF HER CARPENTIER-EDWARDS VALVE AFTER AN IMPLANT DURATION OF TWENTY-NINE (29) MONTHS DUE TO METABOLIC SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417920 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R