BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS-R LARGE

    MDR report key: 6925860 · Received October 6, 2017

    Report

    Report Number
    3005619263-2017-00055
    Event Type
    Death
    Date Received
    October 6, 2017
    Date of Event
    April 24, 2017
    Report Date
    September 19, 2017
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA (VT) TWENTY FOUR HOURS AFTER THE DEVICE IMPLANT. AFTER DRUG TREATMENT, EXTRACOPOREAL MEMBRANE OXYGENATION IMPLANT AND VT ABLATION, THE PATIENT DEVELOPED MULTIPLE ORGAN FAILURE AND SUBSEQUENTLY DIED. A DIAGNOSIS OF SEPTIC SHOCK WAS CONSIDERED AS THE CAUSE OF DEATH DUE TO THE FINDING OF BLOOD CULTURES POSITIVE FOR PSEUDOMONAS AERUGINOSA A FEW DAYS BEFORE THE PATIENT'S DEATH. IT WAS FELT THAT THE INFECTION COULD HAVE CONTRIBUTED TO THE DEVELOPMENT OF MULTIPLE ORGAN FAILURE AND EVENTUALLY LED TO DEATH. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701128 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133EU 17A03001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death