BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 3137926 · Received May 30, 2013

    Report

    Report Number
    2015691-2013-20205
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P010041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, IT NOTED IN MEDICAL RECORDS THAT THE PATIENT HAD ENDOCARDITIS AFTER A DENTAL PROCEDURE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN IMPLANT OF AN EDWARDS TRANSCATHETER BIOPROS VALVE IMPLANT INSIDE OF AN EXISTING EDWARDS BIOPROSTHETIC VALVE (VALVE-IN-VALVE) AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS DUE TO ENDOCARDITIS AND AORTIC REGURGITATION. RECORDS INDICATE, " (B)(6) M W HTN, HYPERLIPIDEMIA, CHB S/P PPM 2001, ATRIAL FIBRILLATION ON COUMADIN, PULM HTN, SEVERE AS AND CAD S/P CABG X3 AND AVR (B)(6) 2010 C/B CHF (LVEF30%) AND PARAVALVULAR LEAK CAUSING AI S/P PERCUTANEOUS PVL REPAIR (B)(6) 2010. BACTEREMIA AND SALIVARIUS ENDOCARDITIS (B)(6) 2012 AFTER A DENTAL PROCEDURE REQUIRING 6 WKS OF ANTIBIOTICS, WHO PRESENTED ON (B)(6) 2013 WITH SOB, FOUND TO HAVE NSTEMI AND SUBSEQUENTLY WENT INTO ACUTE RENAL FAILURE REQUIRING HD STARTING ON (B)(6) 2013, ALSO WITH THROMBOCYTOPENIA, PREOP TTE SHOWED LVEF 35-40 %, MOD DECREASED LV FXN. RV NOT WELL VISUALIZED, MOD SEVERE AR, PASP MILD-MOD ELEVATED ESTIMATED AT 49. CATH (B)(6) SHOWED SIGNIFICANT CAD WITH ONE OCCLUDED GRAFT AND MOD PULM HTN. UNDERWENT RE-OP TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT ON (B)(6) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238807 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2650 R-09L2715

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R