BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3848904 · Received June 4, 2014

    Report

    Report Number
    2015691-2014-01290
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    March 28, 2013
    Report Date
    May 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRUSCHI G, DI MARCO F, BAROSI A, COLOMBO P, BOTTA L, ET AL. SELF-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION FOR AORTIC STENOSIS AFTER MITRAL VALVE SURGERY. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 2013:17:90-95. THE DEVICES WERE NOT RETURNED TO MANUFACTURER, WITHOUT RETURN OF THE DEVICE THE REPORTED CLINICAL OBSERVATIONS CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL UNSUCCESSFUL FOLLOW UPS TO OBTAIN PATIENT AND DEVICE IDENTIFYING INFORMATION WERE MADE WITH NO SUCCESS. 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. EDWARDS MODEL AND DEVICE IDENTIFIERS ARE UNKNOWN FOR BOTH THE AORTIC AND MITAL BIOPROSTHESES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE WAS NOT RETURNED TO MANUFACTURER, WITHOUT RETURN OF THE DEVICE, THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS. ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION VIA A PUBLISHED ARTICLE REGARDING AN EDWARDS AORTIC BIOPROSTHETIC VALVE THAT WAS DIAGNOSED AS DEGENERATED AND STENOTIC AFTER AN UNKNOWN PERIOD OF TIME. PATIENT RECEIVED IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAVR) WITHIN THE EXISTING VALVE. PATIENT IS NOTED TO HAVE BEEN A MALE (B)(6) AT TIME OF IMPLANT. IT IS ALSO NOTED THAT BOTH THE CONVENTIONAL VALVE AND THE TRANSCATHETER VALVE WERE EXPLANTED AND REPLACED WITH A MECHANICAL VALVE 60 DAYS POST TAVR.

    Description of Event or Problem · 1

    BRUSCHI G, DI MARCO F, BAROSI A, COLOMBO P, BOTTA L, ET AL. SELF-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION FOR AORTIC STENOSIS AFTER MITRAL VALVE SURGERY. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 2013:17:90-95. ABSTRACT: OBJECTIVES: TRANSCATHETER AORTIC VALVE IMPLANTATION HAS EMERGED AS A VALUABLE OPTION TO TREAT PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS, WHO ARE NOT BEING CONSIDERED FOR SURGERY BECAUSE OF SIGNIFICANT COMORBIDITIES. CONCERNS EXIST OVER TREATING PATIENTS WHO HAVE PREVIOUSLY UNDERGONE MITRAL VALVE SURGERY FOR POSSIBLE INTERFERENCE BETWEEN THE PERCUTANEOUS AORTIC VALVE AND THE MITRAL PROSTHESIS OR RING. METHODS: AT OUR CENTRE, FROM MAY 2008 TO DECEMBER 2012, 172 PATIENTS (76 MALE) WITH SEVERE SYMPTOMATIC AORTIC STENOSIS WERE ELIGIBLE FOR TRANSCATHETER AORTIC VALVE IMPLANT. NINE PATIENTS, AFFECTED BY SEVERE AORTIC STENOSIS, HAD PREVIOUSLY UNDERGONE MITRAL VALVE SURGERY (4 MONO-LEAFLET, 3 BI-LEAFLET, 1 BIOPROSTHESIS, 1 MITRAL RING); THEY WERE CONSIDERED HIGH-RISK SURGICAL CANDIDATES FOLLOWING JOINT EVALUATION BY CARDIAC SURGEONS AND CARDIOLOGIST AND HAD UNDERGONE TAVI. RESULTS: SEVEN PATIENTS UNDERWENT STANDARD FEMORAL RETROGRADE COREVALVE® (MEDTRONIC INC., MINNEAPOLIS, USA) IMPLANTATION, TWO PATIENTS UNDERWENT A DIRECT AORTIC IMPLANTATION THROUGH A MINI-THORACOTOMY. ALL PATIENTS EXPERIENCED IMMEDIATE IMPROVEMENT OF THEIR HAEMODYNAMIC STATUS. NO DEFORMATION OF THE NITINOL TUBING OF THE COREVALVE, NOR DISTORTION OR MALFUNCTION OF THE MECHANICAL VALVE OR MITRAL RING, OCCURRED AS ASSESSED BY ECHOGRAPHICAL AND FLUOROSCOPIC EVALUATION. NO MAJOR POSTOPERATIVE COMPLICATIONS OCCURRED. IN ALL PATIENTS, ECHOCARDIOGRAPHY IND ICATED NORMAL VALVE FUNCTION DURING FOLLOW-UP. CONCLUSIONS: OUR EXPERIENCE CONFIRMS THE FEASIBILITY OF COREVALVE IMPLANTATION IN PATIENTS WITH MECHANICAL MITRAL VALVES OR MITRAL ANNULOPLASTY RING. EDWARDS WAS INFORMED THROUGH AN ARTICLE THAT THE PATIENT UNDERWENT SURGERY FOR A VALVE-IN-VALVE PROCEDURE WITHIN AN EDWARDS AORTIC BIOPROSTHETIC VALVE, SIZE 23MM, DUE TO DEGENERATION AND STENOSIS AFTER AN IMPLANT DURATION OF APPROX 8 YEARS. AS REPORTED, THE PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK AND SEVERE END-ORGAN DYSFUNCTION. ECHOCARDIOGRAM REVEALED AORTIC BIOPROSTHESIS DEGENERATION WITH SEVERE STENOSIS (PEAK GRADIENT 80MMHG; LVEF 30%) AND A MITRAL VALVE LEAKAGE. PATIENT RECEIVED IMPLANT OF A COREVALVE TRANSCATHETER AORTIC BIOPROSTHETIC VALVE WITHIN THE EXISTING EDWARDS AORTIC VALVE. THE EXACT OCCURRENCE DATE IS UNKNOWN ARTICLE PUBLICATION DATE WILL BE USED AS THE OCCURRENCE DATE. IT IS ALSO NOTED THAT THE DISABLED EDWARDS AORTIC VALVE, THE COREVALVE TRANSCATHETER VALVE AND THE EDWARDS MITRAL VALVE WERE EXPLANTED AND REPLACED WITH MECHANICAL VALVES 60 DAYS AFTER THE TAVI SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325809 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R