BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 5221939 · Received November 13, 2015

    Report

    Report Number
    2015691-2015-03062
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE COMPLETED AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THE ROOT CAUSE FOR THE STENOSIS CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME BUT IT IS LIKELY THAT PATIENT RELATED FACTORS AND PROGRESSION OF DISEASE PROGRESS CONTRIBUTED TO THE EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE IFU WAS REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. NO CORRECTIVE ACTION IS APPLICABLE TO THIS CASE; HOWEVER, 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN PREVIOUSLY REPORTED UNDER MDR# 2015691-2014-02958. THIS IS A DUPLICATE REPORT.

    Description of Event or Problem · 1

    REVIEW OF ARTICLE, ¿CONSECUTIVE PERCUTANEOUS VALVE-IN-VALVE REPLACEMENT LATE AFTER ROSS PROCEDURE: A NOVEL APPROACH IN AN ADULT WITH CONGENITAL HEART DISEASE¿ AUTHOR DR. DOMINIK M. WIKTOR ET AL. ABSTRACT: THE EMERGENCE OF TRANSCATHETER VALVE TECHNOLOGY OVER THE LAST DECADE HAS MADE SIGNIFICANT IMPACT ON THE TREATMENT OF PATIENTS WITH VALVULAR HEART DISEASE. THERE HAS BEEN INCREASING EXPERIENCE WITH BOTH NATIVE AND VALVE-IN-VALVE INDICATIONS WITH PROMISING RESULTS. WE PRESENT THE CASE OF A YOUNG WOMAN WITH CONGENITAL HEART DISEASE WHO UNDERWENT THE ROSS PROCEDURE FOR BICUSPID AORTIC VALVE ENDOCARDITIS WITH SUBSEQUENT REOPERATION AND SURGICAL AORTIC VALVE REPLACEMENT FOR NEO-AORTIC ROOT DILATION WHO EXPERIENCED WORSENING SYMPTOMS RELATED TO BOTH PULMONARY AND AORTIC VALVE DYSFUNCTION. SHE WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS PULMONARY AND AORTIC VALVE REPLACEMENT WITH EXCELLENT EARLY TERM TECHNICAL RESULTS AND MARKED IMPROVEMENT IN SYMPTOMS. IN THIS CASE, A (B)(6) FEMALE PATIENT WITH A 27 MM AORTIC BIOPROSTHETIC VALVE HAD A VALVE-IN-VALVE PROCEDURE WITH A 26 MM SAPIEN XT TRANSCATHETER VALVE DUE TO SEVERE BIOPROSTHETIC AORTIC VALVE STENOSIS. SEVERAL WEEKS PRIOR, THE PATIENT ALSO HAD A TRANSCATHETER PROCEDURE WITH A NON-EDWARDS VALVE IN THE PULMONARY POSITION. THE PATIENT WAS SEEN IN FOLLOW-UP 6 WEEKS AFTER THE AORTIC VALVE-IN-VALVE PROCEDURE AND REPORTED SIGNIFICANT IMPROVEMENT IN HER OVERALL FUNCTIONAL CAPACITY (NYHA FUNCTIONAL CLASS I) AND RESOLUTION OF HER SYMPTOMS OF DYSPNEA. A TRANSTHORACIC ECHOCARDIOGRAM PERFORMED DURING THE VISIT REVEALED CONTINUED EXCELLENT PULMONARY AND AORTIC TRANSCATHETER VALVE FUNCTION WITH GRADIENTS ACROSS BOTH VALVES REMAINING UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751855 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R