BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT

    MDR report key: 14674621 · Received June 13, 2022

    Report

    Report Number
    1649833-2022-00024
    Event Type
    Death
    Date Received
    June 13, 2022
    Date of Event
    June 16, 2014
    Report Date
    July 28, 2022
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001532
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IN PERFORMING A PAPER CRF REVIEW OF THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENTS WERE DISCOVERED FOR SUBJECT AAP-064: ON (B)(6) 2014, 12 DAYS POST IMPLANT, SUBJECT EXPERIENCED VT CAUSING THE PATIENT TO WEAR A LIFE VEST. PATIENT WAS DISCHARGED 3 DAYS LATER. ON (B)(6) 2015, SUBJECT EXPERIENCED SUSTAINED MONOMORPHIC VT AND WAS GIVEN ORAL AMIODARONE LOAD AND DISCHARGED ON (B)(6) 2015. AT TIME OF ADMISSION THE PATIENTS INR WAS 3.0. PER NOTATIONS MADE ON CRF, SUBJECT IS KNOWN TO BE DECEASED BUT CAUSE OF DEATH AND DATE OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181420 ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-25 00851788001532

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other| D