BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONX MITRAL CONFORM 25/33

    MDR report key: 11991289 · Received June 14, 2021

    Report

    Report Number
    1649833-2021-00021
    Event Type
    Death
    Date Received
    June 14, 2021
    Report Date
    August 10, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 07-JUNE-2021 THE PUBLICATION BY HANNA N, CARMONA A, CRESPO H, CUBEDDU RJ. TITLED MECHANICAL TRICUSPID BALLOON ¿VALVULOPLASTY¿ IN A PROHIBITIVE RISK PATIENT WITH CARDIOGENIC SHOCK: A CASE REPORT. EUROPEAN HEART JOURNAL ¿ CASE REPORTS. 2020;4:1-4. REPORTS A PATIENT WITH MULTIPLE COMORBIDITIES, INCLUDING ENDOCARDITIS, PREVIOUS MECHANICAL AVR, AND TRICUSPID REPAIR. ON-X IMPLANTATION IN THE TRICUSPID POSITION HAD AN IMMOBILE LEAFLET THAT WAS SUCCESSFULLY RELEASED BY BALLOON ¿VALVULOPLASTY.¿ THE REASON FOR THE IMMOBILE ON-X LEAFLET WAS UNKNOWN, BUT PATIENT CONDITION RULED OUT RE-OPERATION. AFTER UNSUCCESSFUL ATTEMPTS TO MECHANICALLY FORCE THE LEAFLET OPEN, BALLOON ¿VALVULOPLASTY¿ (INFLATED GRADUALLY TO 8 ATM) RELEASED THE STUCK LEAFLET. ON-X VALVE IN THE TRICUSPID POSITION APPEARS TO HAVE HAD STRUCTURAL DYSFUNCTION (IMMOBILE LEAFLET, NO EVIDENCE OF LEAFLET THROMBOSIS) THAT WAS RELEASED BY BALLOON ¿VALVULOPLASTY,¿ BUT PATIENT DIED 5 DAYS POSTOP OF MULTISYSTEM ORGAN FAILURE. CASE STUDY OF ON-X VALVE IN THE TRICUSPID POSITION (AN OFF LABEL APPLICATION). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 07-JUNE-2021 THE PUBLICATION BY HANNA N, CARMONA A, CRESPO H, CUBEDDU RJ. TITLED MECHANICAL TRICUSPID BALLOON ¿VALVULOPLASTY¿ IN A PROHIBITIVE RISK PATIENT WITH CARDIOGENIC SHOCK: A CASE REPORT. EUROPEAN HEART JOURNAL ¿ CASE REPORTS. 2020;4:1-4. REPORTS A PATIENT WITH MULTIPLE COMORBIDITIES, INCLUDING ENDOCARDITIS, PREVIOUS MECHANICAL AVR, AND TRICUSPID REPAIR. ON-X IMPLANTATION IN THE TRICUSPID POSITION HAD AN IMMOBILE LEAFLET THAT WAS SUCCESSFULLY RELEASED BY BALLOON ¿VALVULOPLASTY.¿ THE REASON FOR THE IMMOBILE ON-X LEAFLET WAS UNKNOWN, BUT PATIENT CONDITION RULED OUT RE-OPERATION. AFTER UNSUCCESSFUL ATTEMPTS TO MECHANICALLY FORCE THE LEAFLET OPEN, BALLOON ¿VALVULOPLASTY¿ (INFLATED GRADUALLY TO 8 ATM) RELEASED THE STUCK LEAFLET. ON-X VALVE IN THE TRICUSPID POSITION APPEARS TO HAVE HAD STRUCTURAL DYSFUNCTION (IMMOBILE LEAFLET, NO EVIDENCE OF LEAFLET THROMBOSIS) THAT WAS RELEASED BY BALLOON ¿VALVULOPLASTY,¿ BUT PATIENT DIED 5 DAYS POSTOP OF MULTISYSTEM ORGAN FAILURE. CASE STUDY OF ON-X VALVE IN THE TRICUSPID POSITION (AN OFF LABEL APPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889484 ONX MITRAL CONFORM 25/33 HEART-VALVE MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXMC-25/33

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| L