BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 7207026 · Received January 19, 2018

    Report

    Report Number
    3005791775-2018-00003
    Event Type
    Death
    Date Received
    January 19, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 19, 2018
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT'S PROCLIVITY FOR BLEEDING WAS DEMONSTRATED MULTIPLE TIMES PRIOR TO UROLIFT SYSTEM PROCEDURE. ANTICOAGULATION MEDICATIONS CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE BLEEDING. BLOOD LOSS AND ASSOCIATED HYPOVOLEMIA MAY HAVE CONTRIBUTED TO THE ST ELEVATED MYOCARDIAL INFARCTION AND SUBSEQUENT CARDIAC ARREST. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF CHRONIC ATRIAL FIBRILLATION WITH PACEMAKER, MITRAL VALVE REPLACEMENT, BACTERIAL ENDOCARDITIS, HYPERTENSION, HYPERLIPIDEMIA, AND TRANSIENT ISCHEMIC ATTACK. HE WAS EXPERIENCING PROGRESSIVE LOWER URINARY TRACT SYMPTOMS, HAD FAILED MEDICAL THERAPY, AND SOUGHT DEFINITIVE TREATMENT, WHICH WAS DETERMINED TO BE THE UROLIFT SYSTEM. THE PATIENT DISCONTINUED HIS DAILY WARFARIN ANTICOAGULATION AND WAS BEING BRIDGED WITH ENOXAPARIN IN PREPARATION FOR THE UROLIFT PROCEDURE. THE PATIENT WAS TREATED WITH THE UROLIFT SYSTEM ON (B)(6) 2017. THE DEVICE PERFORMED AS INTENDED AND NO BLEEDING WAS NOTED AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT A CATHETER AND RESTARTED WARFARIN ANTI-COAGULATION. ON (B)(6) 2017, WHILE ON BOTH WARFARIN AND ENOXAPARIN, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RETROPERITONEAL BLEEDING, HEMATURIA AND CLOT RETENTION. AS NOTED IN THE MEDICAL HISTORY, THE PATIENT HAS HAD RECURRENT RETROPERITONEAL BLEEDS PRIOR TO HAVING THE UROLIFT SYSTEM PROCEDURE. A CT SCAN SHOWED A MODERATE AMOUNT OF RETROPERITONEAL HEMORRHAGE. THE PATIENT WAS ADMITTED TO THE ICU DUE TO HYPOVOLEMIC SHOCK AND ANTICOAGULATION WAS WITHHELD. CREATININE LEVELS SUGGESTED ACUTE KIDNEY INJURY (3.3 MG/DL FROM BASELINE OF 1.1 MG/DL). HE WAS GIVEN IV FLUIDS AND 2 UNITS OF PACKED RED BLOOD CELLS. ON (B)(6) 2017, THE PATIENT'S HEMOGLOBIN AND CT SCAN APPEARED STABLE. A HEPARIN DRIP WITHOUT BOLUS WAS INITIATED. HEMOGLOBIN DROPPED TO 7.9 G/DL AND THE PATIENT RECEIVED ANOTHER 2 UNITS OF PACKED BLOOD CELLS. HEMOGLOBIN LEVEL STABILIZED AND WAS LAST RECORDED AT 8.8 G/DL. ON (B)(6) 2017, THE CARDIAC MONITOR RHYTHM INDICATED ST ELEVATION. THE PATIENT EXPIRED DUE TO CARDIAC ARREST AT 4:31 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50444 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death WARFARIN, ENOXAPARIN