BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE H10

    MDR report key: 3430552 · Received October 25, 2013

    Report

    Report Number
    2015691-2013-21401
    Event Type
    Death
    Date Received
    October 25, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME AND MODEL NUMBER: SIMILAR TO MODEL 2800; CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS WHICH IS SOLD AND MARKETED IN THE US. STENOSIS OF AN IMPLANTED VALVE, LIKE REGURGITATION, MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION. THERE ARE CASES OF SVD THAT RESULT IN A COMBINATION OF REGURGITATION AND STENOSIS. IT MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IN THESE CASES, IT CAUSES THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE. STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SHORTNESS OF BREATH AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO AUTOPSY WAS PERFORMED AND PATIENT'S CAUSE OF DEATH REMAINS UNKNOWN. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT EXPIRED APPROXIMATELY 12 MONTHS AFTER IMPLANT DUE TO UNKNOWN REASONS. BASED ON THE FOLLOW-UP WITH THE SURGEON, "THE PATIENT DID NOT HAVE ANY NOTED CLOTTING DISORDER. HE HAD ALWAYS BEEN IN SINUS RHYTHM. NO HISTORY OF VENOUS THROMBOSIS NEITHER PULMONARY EMBOLISM. NO KNOWN RISKS OF PROSTHETIC VALVE THROMBOSIS. PATIENT WAS DISCHARGED WITH ANTICOAGULANT AND ANTIAGGREGATION (ASPIRIN) THERAPY BECAUSE DURING SURGERY IT WAS ALSO PERFORMED AN AORTO-CORONARY BYPASS WITH THE INTERNAL MAMMARY ARTERY ON IVA: PATIENT KEPT ON WITH ANTICOAGULANTS FOR 6 WEEKS, AND THEN HE MAINTAINED THE ANTIAGGREGATION THERAPY ONLY." POST OPERATIVE ECHO PERFORMED ON (B)(6) 2012, THE AORTIC BIOPROSTHESIS IS IN NORMAL POSITION AND WITH NORMAL FUNCTION. ECHO PERFORMED ON JUN 2013 SHOWED GRADIENT OF 73/48MMHG. THE SURGEON ALSO NOTED THAT IT IS IMPOSSIBLE TO UNDERSTAND WHAT COULD EXPLAIN THIS RAPID INCREASE OF GRADIENT. NO AUTOPSY WAS DONE. PATIENT DIED AT HOME. NO OTHER DETAILS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548665 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 S-12D1172

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death