BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 8430631 · Received March 18, 2019

    Report

    Report Number
    2015691-2019-00925
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 21, 2019
    Report Date
    February 21, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA: 20-00141.

    Additional Manufacturer Narrative · 0

    F10: #3191 = VALVE THROMBUS. 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. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. 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. VALVE THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION OF PROSTHETIC VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. IMMEDIATE INTERVENTION, EITHER BY THROMBOLYTIC THERAPY OR VALVE REPLACEMENT IS REQUIRED FOR SIGNIFICANT THROMBOSIS. ALTERNATIVELY, THERE MAY BE CASES WHERE THE PATIENT IS PLACED ON AN ANTICOAGULANT TO TREAT THROMBOSIS. IN THIS CASE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 33MM EDWARDS VALVE IN THE TRICUSPID POSITION WAS CONSIDERED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO CALCIFICATION AND THROMBUS. PATIENT WAS NOTED TO BE DOING WELL AND ASYMPTOMATIC.

    Additional Manufacturer Narrative · 1

    STENOSIS AND/OR REGURGITATION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS AND/OR REGURGITATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN PERFORMED; HOWEVER, THE HEALTHCARE PROVIDER HAS NOT PROVIDED ANY ADDITIONAL DETAILS REGARDING THIS EVENT. ALTHOUGH THE REASON FOR THE VALVE-IN-VALVE IS UNKNOWN, THERE HAS BEEN NO ALLEGATION OF PRODUCT MALFUNCTION OR DEFICIENCY. THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THIS EVENT REMAINS INDETERMINABLE. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 33MM EDWARDS VALVE IN THE TRICUSPID POSITION WAS CONSIDERED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION, FOR UNKNOWN REASONS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223917 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R