BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD PERIPHERAL VASCULAR RECOVER FILTER

    MDR report key: 647797 · Received November 7, 2005

    Report

    Report Number
    647797
    Event Type
    Death
    Date Received
    November 7, 2005
    Date of Event
    October 18, 2005
    Report Date
    October 31, 2005
    Manufacturer
    BARD
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TREATED FOR DVT WITH ANTICOAGULANTS. EXPERIENCED A GI BLEED WHICH PROMPTED PLACEMENT OF RECOVERY IVC FILTER IN 2005. DISCHARGED WITH NO APPARENT PROBLEMS. PRESENTED TO ED EIGHTEEN DAYS LATER AT 0055 WITH LOWER QUADRANT ABDOMINAL PAIN. CT OF ABDOMEN AND PELVIS PERFORMED. SHOWED SMALL INGUINAL HERNIA. OF NOTE IS THAT IVC FILTER WAS IN PLACE. DISCHARGED HOME AT 1255. PER FAMILY, BY THE TIME PT REACHED HOME, HE WAS SOB AND ASHEN, BECAME UNRESPONSIVE. ARRIVED BACK IN ED AT 1420 IN PULSELESS ELECTRICAL ACTIVITY ARREST. CPR PERFORMED, BP NORMALIZED ON HIGH DOSES OF LEVOPHED. TEMPORARY TRANSCUTANEOUS PACER PLACED WITH RATE AT 70. EKG SHOWED DIFFERENT MORPHOLOGY TO BASELINE OF LBBB. EKG SHOWED RBBB WITH DYNAMIC ST SEGMENT CHANGES, INDICATIVE OF ISCHEMIC EVENT. PT TAKEN TO CARDIAC CATHETERIZATION LAB WITH INTENTION OF PERFORMING A DIAGNOSTIC CARDIAC CATHETERIZATION AND ANGIOPLASTY IF NEEDED. WHEN ANGIOGRAPHY FILMS WERE TAKEN, IVC FILTER WAS IN THE RIGHT VENTRICLE WITH THE LEGS OF THE DEVICE LODGED IN THE TRICUSPID VALVE, PROTRUDING INTO THE ATRIUM. ATTEMPTS WERE MADE TO TRANSFER PT EMERGENTLY VIA HELICOPTER FOR SALVAGE REMOVAL OF THE DEVICE FROM THE RIGHT HEART. PT HAD TWO EPISODES OF BRADYCARDIAC ARREST IN THE CATH LAB AND WAS NEVER ABLE TO REGAIN ANY HEMODYNAMIC STABILITY DESPITE CPR AND HIGH DOSES OF LEVOPHED, DOPAMINE, CONTINUOUS BICARBONATE DRIP, EPINEPHRINE AND ATROPINE. PT PRONOUNCED DEAD AT 1657 SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERIPHERAL VASCULAR RECOVER FILTER * DTK BARD RF048F GFPD 4721

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death