BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 5417160 · Received February 8, 2016

    Report

    Report Number
    2124215-2016-02362
    Event Type
    Injury
    Date Received
    February 8, 2016
    Date of Event
    July 29, 2014
    Report Date
    December 22, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MULTIPLE CO-MORBIDITIES WHO RECEIVED A SUCCESSFULLY IMPLANTED LOTUS BOSTON SCIENTIFIC PERCUTANEOUS AORTIC VALVE TRANSFEMORALLY IN (B)(6) 2014. ONE WEEK LATER THE PATIENT NEEDED A PACEMAKER DUE TO COMPLETE AV BLOCK. TWO MONTHS LATER ((B)(6) 2014), HE PRESENTED AN INFECTIOUS ENDOCARDITIS DUE TO STREPTOCOCCUS GALLOLYTICUS, A BACTERIA OF GUT ORIGIN, IN CONNECTION WITH A DIVERTICULITIS THE PATIENT SUFFERED CHRONICALLY, WHICH CAUSED REPEATED EPISODES OF BACTEREMIA AND ORIGINATED THE ENDOCARDITIS. THE INFECTION WAS NOT RELATED TO THE PROSTHESIS OR THE IMPLANTATION TECHNIQUE. ALSO, THE INFECTION WAS NOT RELATED TO THE PACEMAKER OR THE IMPLANTATION TECHNIQUE. THE ACUTE ENDOCARDITIS AFFECTED ALSO THE MITRAL VALVE WITH ACUTE VALVE RUPTURE, AND WAS THE PRINCIPAL FACTOR THAT LED TO ACUTE HEART FAILURE AND DEATH. AS A CONSEQUENCE OF THE BACTERIEMIA OF ENDOCARDITIS THE PATIENT SUFFERED ALSO A VEGETATION ON THE LEAD, AND THIS ALSO CONTRIBUTE TO THE SEPSIS BUT THE ACUTE HEART FAILURE WAS PRINCIPALLY INFLUENCED BY THE MITRAL VALVE RUPTURE. THE INFECTION AND THE CAUSE OF DEATH WAS INDEPENDENT OF BRAND OR TYPE OF DEVICE. INFECTIVE ENDOCARDITIS IN A PATIENT WITH TRANSCATHETER LOTUS VALVE; (B)(6), REV ESP CARDIOL. 2015;68(12):1174

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE INVOLVING A (B)(6) HYPERTENSIVE MAN, WHO WAS AN EX-SMOKER WITH RESPIRATORY AND RENAL COMORBIDITIES, PRESENTED WITH SEVERE, SYMPTOMATIC AORTIC STENOSIS. DUE TO HIS HIGH SURGICAL RISK, THE PHYSICIAN SUCCESSFULLY IMPLANTED A BOSTON SCIENTIFIC LOTUS PERCUTANEOUS AORTIC VALVE TRANSFEMORALLY, WITH SUITABLE DEPTH ON (B)(6) 2014. IMPLANTATION OF A BOSTON SCIENTIFIC INGENIO MRI VR PACEMAKER AND FLEXTEND 2 LEAD ON (B)(6) 2014 WAS ALSO REQUIRED, DUE TO COMPLETE ATRIOVENTRICULAR BLOCK. APPROXIMATELY TWO MONTHS LATER (LATE-(B)(6) 2014), THE PATIENT WAS ADMITTED TO HOSPITAL FOR ACUTE PULMONARY EDEMA, AND A NEW GRADE V/VI SYSTOLIC MURMUR WAS AUSCULTATED IN MITRAL FOCUS. THE TRANSTHORACIC ECHOCARDIOGRAM REVEALED A THICKENED AND PERFORATED ANTERIOR MITRAL LEAFLET, CAUSING SEVERE MITRAL REGURGITATION. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED THAT THE ANTERIOR MITRAL LEAFLET HAD HETEROGENEOUS ECHOGENICITY AND IRREGULAR MARGINS, SUGGESTIVE OF AN ABSCESS. THE PROSTHETIC AORTIC RING AND ITS LEAFLETS WERE THICKENED AND HAD A MOBILE AND FILIFORM STRUCTURE COMPATIBLE WITH VEGETATION. MOREOVER, VEGETATION WAS VISIBLE IN THE PACEMAKER LEAD (FIGURE 2B AND VIDEO 3 OF THE SUPPLEMENTARY MATERIAL). SERIAL BLOOD CULTURES ISOLATED STREPTOCOCCUS GALLOLYTICUS. IN VIEW OF THE DIAGNOSIS OF EARLY INFECTIVE ENDOCARDITIS OF THE AORTIC VALVE COMPLICATED BY SEVERE MITRAL REGURGITATION DUE TO VALVE RUPTURE AND PACEMAKER LEAD ENDOCARDITIS, THE CASE WAS DISCUSSED WITH THE CARDIAC SURGERY TEAM, WHO RULED OUT SURGERY DUE TO THE HIGH RISK. THE PATIENT DIED 48 HOURS LATER ON (B)(6) 2014 DUE TO SEVERE SEPSIS AND HEART FAILURE. CLINICAL AUTOPSY CONFIRMED THE DIAGNOSIS. THIS IS THE FIRST KNOWN CASE OF INFECTIVE ENDOCARDITIS IN A PATIENT WITH A LOTUS PERCUTANEOUS AORTIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76035 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R J175