BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART-VALVE, REPLACEMENT

    MDR report key: 8094619 · Received November 21, 2018

    Report

    Report Number
    2015691-2018-04836
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    January 1, 2012
    Report Date
    October 31, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER IS UNKNOWN. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ARTICLE "TRANSCATHETER AORTIC VALVE REPLACEMENT FOR DEGENERATIVE BIOPROSTHETIC SURGICAL VALVES: RESULTS FROM THE GLOBAL VALVE-IN-VALVE REGISTRY" IN CIRCULATION 2012; 126: 2335-2344. DOI: 10.1161/CIRCULATIONAHA.112.104505. BACKGROUND: TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION IS AN EMERGING THERAPEUTIC ALTERNATIVE FOR PATIENTS WITH A FAILED SURGICAL BIOPROSTHESIS AND MAY OBVIATE THE NEED FOR REOPERATION. WE EVALUATED THE CLINICAL RESULTS OF THIS TECHNIQUE USING A LARGE, WORLDWIDE REGISTRY. METHODS AND RESULTS: THE GLOBAL VALVE-IN-VALVE REGISTRY INCLUDED 202 PATIENTS WITH DEGENERATED BIOPROSTHETIC VALVES (AGED 77.7 PLUS OR MINUS 10.4 YEARS 52.5% MEN) FROM 38 CARDIAC CENTERS. BIOPROSTHESIS MODE OF FAILURE WAS STENOSIS (N85 42%), REGURGITATION (N68 34%), OR COMBINED STENOSIS AND REGURGITATION (N49 24%). IMPLANTED DEVICES INCLUDED COREVALVE (N124) AND EDWARDS SAPIEN (N78). PROCEDURAL SUCCESS WAS ACHIEVED IN 93.1% OF CASES. ADVERSE PROCEDURAL OUTCOMES INCLUDED INITIAL DEVICE MALPOSITION IN 15.3% OF CASES AND OSTIAL CORONARY OBSTRUCTION IN 3.5%. AFTER THE PROCEDURE, VALVE MAXIMUM / MEAN GRADIENTS WERE 28.4 PLUS OR MINUS 14.1 / 15.9 PLUS OR MINUS 8.6 MM HG, AND 95% OF PATIENTS HAD 1 DEGREE OF AORTIC REGURGITATION. AT 30-DAY FOLLOW-UP, ALL-CAUSE MORTALITY WAS 8.4%, AND 84.1% OF PATIENTS WERE AT NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS I / II. ONE-YEAR FOLLOW-UP WAS OBTAINED IN 87 PATIENTS, WITH 85.8% SURVIVAL OF TREATED PATIENTS. CONCLUSIONS: THE VALVE-IN-VALVE PROCEDURE IS CLINICALLY EFFECTIVE IN THE VAST MAJORITY OF PATIENTS WITH DEGENERATED BIOPROSTHETIC VALVES. SAFETY AND EFFICACY CONCERNS INCLUDE DEVICE MALPOSITION, OSTIAL CORONARY OBSTRUCTION, AND HIGH GRADIENTS AFTER THE PROCEDURE. THIS EVENT IS TO INVESTIGATE FIGURE 1, A. A PATIENT WITH AN EDWARDS VALVE IMPLANTED FOR AN UNKNOWN IMPLANT DURATION UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THERE WAS REPORTED TO BE DEVICE MALPOSITION AND OSTIAL CORONARY OBSTRUCTION DURING AORTIC VALVE-IN-VALVE IMPLANTATION. A NON-EDWARDS VALVE EMBOLIZED DURING IMPLANTATION INSIDE THE FAILING EDWARDS VALVE FOLLOWED BY DELIVERY OF A SECOND NON-EDWARDS VALVE IN A CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936909 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention