BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 4144024 · Received October 3, 2014

    Report

    Report Number
    3002124545-2014-00026
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CASE OF POSSIBLE USER ERROR. ACCORDING TO THE ANALYSIS PERFORMED BY THE HOSPITAL, THE ROOT CAUSE ANALYSIS REVEALED THAT THE MEDICAL EVENT RESULTED FROM: A LIVER TO LUNG SHUNT FROM THE LEFT HEPATIC ARTERY FROM A COMPLICATED ARTERIOVENOUS SHUNTING PATHWAY INVOLVING 2 SHUNTS, AND THE LEFT HEPATIC ARTERY WAS NOT ASSAYED WITH A PRETREATMENT TCMAA TO DETERMINE IF THERE WAS SIGNIFICANT LIVER TO LUNG SHUNTING. HOWEVER, THE METHOD USED TO CALCULATE THE ACTIVITY TO THE LUNGS IS NOT A RECOGNIZED METHOD SO THE TRUE DOSE TO THE LUNGS IS NOT KNOWN. THE RECOMMENDED UPPER LIMIT OF DOSE TO THE LUNGS FROM A SINGLE THERASPHERE TREATMENT IS 30 GY, AND THE CUMULATIVE DOSE FROM MULTIPLE TREATMENTS IS 50 GY.

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) YEAR OLD MALE WHO HAS MULTIFOCAL HCC 92 LESIONS IN RIGHT LOBE OF THE LIVER AND ONE LESION IN CAUDATE LOBE) WITH RAPIDLY RISING AFP. MRI REVEALED LEFT PORTAL VEIN THROMBOSIS FROM THE CAUDATE LIVER LESION. ON (B)(6) 2014, A HEPATIC ARTERIOGRAM AND A TCMAA LIVER/LUNG SHUNT NUCLEAR MEDICINE STUDY WERE PERFORMED. THE RIGHT HEPATIC ARTERY WAS USED FOR THE TCMAA SINCE THAT LOBE HAD THE LARGEST TUMOR BURDEN. THE LIVER TO SHUNT FRACTION WAS CALCULATED TO BE 4.95%. THE LEFT HEPATIC ANGIOGRAM SHOWED PORTAL SHUNTING AND IT WAS ALSO DETERMINED THAT THE RIGHT GASTRIC AND GASTRODUODENAL ARTERIES WERE BOTH WITHIN CLOSE PROXIMITY TO WHERE THE CATHETER WOULD NEED TO BE PLACED IN ORDER TO TREAT THIS AREA WITH THERASPHERE THEREFORE, COILING OF THE GDA AND RIGHT GASTRIC WOULD BE REQUIRED PRIOR TO Y-90 DELIVERY TO THE LEFT LOBE OF THE LIVER VIA THE LEFT HEPATIC ARTERY. A DOSE OF 117 GY WAS PRESCRIBED TO THE LEFT LOBE. ON (B)(6) 2014, THE THERASPHERES WERE ADMINISTERED TO THE PATIENT. THE PATIENT UNDERWENT POST-TREATMENT IMAGING ON (B)(6) 2014. TUMOR SPECT IMAGING AND PET CT IMAGING SHOWED ACTIVITY IN THE LEFT LOBE OF THE LIVER, BUT THERE WAS ALSO SUBSTANTIAL ACTIVITY IN THE BILATERAL LUNGS. ESTIMATED DOSE OF 35 GY TO LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617638 THERASPHERE YTTRIUM-90 NUCRISOGERES NAW BIOCOMPATIBLES U.K. LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other