BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3414998 · Received October 17, 2013

    Report

    Report Number
    2015691-2013-21319
    Event Type
    Death
    Date Received
    October 17, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ARTICLE: LONG-TERM RESULTS OF CEP BIOPROSTHESES FOR RIGHT SIDE HEART. DATE PUBLISHED: 2013 IN ARTIFICIAL ORGAN SUITES, VOL. 42, NO. 2 [BACKGROUND]: FOR VALVE REPLACEMENTS AT THE RIGHT SIDE HEART, USING BIOPROSTHETIC VALVE IS THE FIRST CHOICE AT OUR FACILITY. SINCE 1985, USING THE CEP BIOPROSTHETIC VALVES IS THE FIRST CHOICE. [PURPOSE]: THIS STUDY FOCUSES ON REVIEWING THE LONG-TERM RESULTS OF TRICUSPID VALVE REPLACEMENT AND PULMONARY VALVE REPLACEMENT AND TO DETERMINE THE APPROPRIATENESS OF USING THE CEP VALVES. [TARGET] 28 TVR CASES AND 39 PVR CASES WHICH WERE PERFORMED FROM MARCH 1985 TO APRIL 2013. TRACKING ACHIEVEMENT RATE WAS 97.0%. [RESULTS]: THERE WERE 11 CONGENITAL CARDIAC DISEASES AND 17 COMBINED VALVULAR DISEASES AS BASIC DISEASE FOR TVR GROUP. THERE WERE 36 CONGENITAL CARDIAC DISEASES AND 3 COMBINED VALVULAR DISEASES AS BASIC DISEASE FOR PVR GROUP. MOST PATIENTS IN PVR GROUP HAD CONGENITAL CARDIAC DISEASES. PATIENT AGE FOR PVR GROUP (2.4 YOUNGER OR OLDER THAN 31 YEARS OLD) WAS SIGNIFICANTLY YOUNGER THAN TVR GROUP (3.6 YOUNGER OR OLDER THAN 49 YEARS OLD). THREE PATIENTS EXPIRED AT SURGERY IN TVR GROUP (11%). ONE PATIENT EXPIRED AT SURGERY IN PVR GROUP (2.6%). THE SURVIVAL RATE AFTER 5 YEARS FROM SURGERY WAS 84% (TVR) VERSUS 97% (PVR). THE SURVIVAL RATE AFTER 10 YEARS FROM SURGERY WAS 52% (TVR) VERSUS 97% (PVR). THE SURVIVAL RATE AFTER 20 YEARS FROM SURGERY WAS 41% (TVR) VERSUS 97% (PVR). THE SURVIVAL RATE (DEATH RELATED TO HEART) AFTER 5 YEARS FROM SURGERY WAS 95% VERSUS 100%. THE SURVIVAL RATE (DEATH RELATED TO HEART) AFTER 10 YEARS FROM SURGERY WAS 73% VERSUS 100%. THE SURVIVAL RATE (DEATH RELATED TO HEART) AFTER 20 YEARS FROM SURGERY WAS 59% VERSUS 100%. TVR GROUP SIGNIFICANTLY HAD POOR RESULTS OF THE SURVIVAL RATE (DEATH RELATED TO HEART). HOWEVER, THE SURVIVAL RATE (DEVICE RELATED) AFTER 5 YEARS FROM SURGERY WAS 100% VERSUS 100%. THE SURVIVAL RATE (DEVICE RELATED) AFTER 10 YEARS FROM SURGERY WAS 84% VERSUS 100%. THE SURVIVAL RATE (DEVICE RELATED) AFTER 20 YEARS FROM SURGERY WAS 84% VERSUS 100%. THERE WAS NO SIGNIFICANT DEFERENCE BETWEEN THE TWO GROUPS FOR THE SURVIVAL RATE (DEVICE RELATED). THERE WAS NO THROMBOEMBOLIC EVENT. THERE WERE 4 HEMORRHAGIC EVENTS; HOWEVER, 3 CASES WERE DUE TO MVR WITH A MECHANICAL VALVE. THERE WERE 3 STRUCTURAL VALVE DETERIORATION (SVD) CASES IN TVR GROUP AND 2 SVD CASES IN PVR GROUP. THE EVENT-FREE (SVD) RATE AFTER 5 YEARS FROM SURGERY WAS 95% VERSUS 100%. THE EVENT-FREE (SVD) RATE AFTER 10 YEARS FROM SURGERY WAS 95% VERSUS 90%. THE EVENT-FREE (SVD) RATE AFTER 20 YEARS FROM SURGERY WAS 73% VERSUS 45%. FOR 4 RE-TVR CASES AND 2 RE-PVR CASES, THE EVENT-FREE RATE AFTER 5 YEARS FROM SURGERY WAS 95% VERSUS 100%, THE EVENT-FREE RATE AFTER 10 YEARS FROM SURGERY WAS 95% VERSUS 90%, THE EVENT-FREE RATE AFTER 20 YEARS FROM SURGERY WAS 54% VERSUS 45%, AND THERE WAS NO SIGNIFICANT DEFERENCE BETWEEN THE TWO GROUPS. [CONCLUSION] FOR CASES USING CEP VALVE FOR VALVE REPLACEMENT AT RIGHT-SIDE HEART, DEATH RATE RELATED TO THE VALVE, THE RATE FOR DEVELOPMENT OF THROMBOEMBOLIC AND THE RATE FOR DEVELOPMENT OF HEMORRHAGIC EVENT ARE LOW. THE EVENT (SVD)-FREE RATE AFTER 20 YEARS FROM SURGERY AND THE EVENT(SURGERY)-FREE RATE WERE MORE THAN 45%. VALVE REPLACEMENT FOR RIGHT-SIDE HEART IS PERFORMED OFTEN FOR YOUNG PATIENTS; HOWEVER, CHOOSING BIOPROSTHETIC VALVE IS REASONABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS LEARNED THROUGH AN ARTICLE PUBLISHED IN 2013 IN ARTIFICIAL ORGAN SUITES, VOL. 42, NO. 2 TITLED "LONG-TERM RESULTS OF CEP BIOPROSTHESES FOR RIGHT SIDE HEART". ARTICLE CONCLUSION: FOR CASES USING CEP VALVE FOR VALVE REPLACEMENT AT RIGHT-SIDE HEART, DEATH RATE RELATED TO THE VALVE, THE RATE FOR DEVELOPMENT OF THROMBOEMBOLIC AND THE RATE FOR DEVELOPMENT OF HEMORRHAGIC EVENT ARE LOW. THE EVENT (SVD)-FREE RATE AFTER 20 YEARS FROM SURGERY AND THE EVENT(SURGERY)-FREE RATE WERE MORE THAN 45%. VALVE REPLACEMENT FOR RIGHT-SIDE HEART IS PERFORMED OFTEN FOR YOUNG PATIENTS; HOWEVER, CHOOSING BIOPROSTHETIC VALVE IS REASONABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533280 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R