BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONX ASCENDING AORTIC 23

    MDR report key: 14744866 · Received June 20, 2022

    Report

    Report Number
    1649833-2022-00032
    Event Type
    Death
    Date Received
    June 20, 2022
    Report Date
    August 12, 2022
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001662
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT,"SUBJECT: AAP- 095 ON (B)(6) 2019 454 DAYS POST IMPLANT, SUBJECT EXPERIENCED A PERIPHERAL VASCULAR DISEASE WHICH RESULTED IN AXILLARY BI-FEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTERECTOMY. AT TIME OF REINTERVENTION THE SUBJECTS INR WAS 1.1. ON (B)(6) 2020, THE SUBJECT EXPERIENCED AN ACUTE CVA AND WAS DIAGNOSED WITH LUNG CANCER WHICH RESULTED IN A READMISSION. DURING THEIR TIME IN THE HOSPITAL THE SUBJECT EXPERIENCED ACUTE RESPIRATORY FAILURE AND WENT INTO CARDIAC ARREST WHICH RESULTED IN DEATH ON (B)(6) 2014, 31 DAYS AFTER HOSPITALIZATION. SUBJECT IN THE POST MARKET STUDY: OX1901.000-M (11/20)- POST MARKET CLINICAL FOLLOW UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY. PI: [SURGEON]. WHILE ARTIVION REPRESENTATIVE WAS PERFORMING PAPER CRF REVIEW, ADVERSE EVENTS WERE DISCOVERED AS THEY WERE DOCUMENTED IN CRF SUBMITTED FOR STUDY. MEDICAL RECORDS/SOURCE DOCUMENTATION HAS NOT BEEN PROVIDED FOR REVIEW AND WILL NOT LIKELY BE OBTAINED. GIVEN THE RETROSPECTIVE NATURE, THESE EVENTS ARE NOT CURRENT. (STUDY TIMELINE IS 2008-2018). IDENTIFIED EVENTS WERE REPORTED TO FIELD ASSURANCE IN A PER SUBJECT REPORT.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "SUBJECT: (B)(6) ON 20MAR2019 454 DAYS POST IMPLANT, SUBJECT EXPERIENCED A PERIPHERAL VASCULAR DISEASE WHICH RESULTED IN AXILLARY BI-FEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTECTOMY. AT TIME OF REINTERVENTION THE SUBJECTS INR WAS 1.1. ON (B)(6) 2020, THE SUBJECT EXPERIENCED AN ACUTE CVA AND WAS DIAGNOSED WITH LUNG CANCER WHICH RESULTED IN A READMISSION. DURING THEIR TIME IN THE HOSPITAL THE SUBJECT EXPERIENCED ACUTE RESPIRATORY FAILURE AND WENT INTO CARDIAC ARREST WHICH RESULTED IN DEATH ON (B)(6) 2020, 31 DAYS AFTER HOSPITALIZATION. SUBJECT IN THE POST MARKET STUDY: OX1901.000-M (11/20)- POST MARKET CLINICAL FOLLOW UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY. PI: [SURGEON)]. WHILE ARTIVION REPRESENTATIVE WAS PERFORMING PAPER CRF REVIEW, ADVERSE EVENTS WERE DISCOVERED AS THEY WERE DOCUMENTED IN CRF SUBMITTED FOR STUDY. MEDICAL RECORDS/SOURCE DOCUMENTATION HAS NOT BEEN PROVIDED FOR REVIEW AND WILL NOT LIKELY BE OBTAINED. GIVEN THE RETROSPECTIVE NATURE, THESE EVENTS ARE NOT CURRENT. (STUDY TIMELINE IS 2008-2018). IDENTIFIED EVENTS WERE REPORTED TO FIELD ASSURANCE IN A PER SUBJECT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847189 ONX ASCENDING AORTIC 23 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-23 00851788001662

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| D