BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 11762807 · Received May 3, 2021

    Report

    Report Number
    3002124543-2021-00013
    Event Type
    Death
    Date Received
    May 3, 2021
    Date of Event
    July 29, 2020
    Report Date
    May 3, 2021
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT HEMORRHAGIC SHOCK AND DEATH OCCURRED. SUBJECT (B)(6) WAS ENROLLED INTO (B)(6) STUDY IN (B)(6) 2020 AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF INFUSION WAS SELECTIVE AND 2.1GBQ WERE ADMINISTERED TO THE LIVER THROUGH VIAL 1. VOLUME OF TOTAL PERFUSED LIVER WAS 1445 CM^3. IN (B)(6) 2020, 86 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH COMPLAINTS OF ABUNDANT BLOOD IN STOOL LEADING INTO SHOCK, WITH HEART RATE OF 140 BEATS/ MIN AND LOW BLOOD PRESSURE AT 65/30 MMHG. THE SUBJECT WAS PALE, SHORT OF BREATH AND ALSO BECAME HYPOGLYCEMIC (1.7 MMOL/L) AND WAS HOSPITALIZED ON SAME DAY FOR FURTHER EVALUATION. ON ADMISSION, SUBJECT WAS WELL ORIENTED. ABDOMEN WAS SOFT, DISTENDED AND WITH ASCITES; LEG SWELLING WITH JUGULAR TURGESCENCE WAS SEEN; NORMAL HEART SOUNDS ON AUSCULTATION. THE SUBJECT WAS NOTED TO BE IN HEMORRHAGIC SHOCK, WHICH, PER SOURCE, WAS SECONDARY TO GASTROINTESTINAL HEMORRHAGE SECONDARY TO RUPTURED ESOPHAGEAL VARICES. OF NOTE, THE SUBJECT HAD ESOPHAGEAL VARICES LIGATION IN (B)(6) 2019. TWO AMPOULES OF G30 GLUCOSE WAS ADMINISTERED ALONG WITH FLUID THERAPY. THE SUBJECT WAS UNRESPONSIVE TO FLUID THERAPY BY CRYSTALLOIDS AT 1.5 L; HENCE, A RIGHT FEMORAL CENTRAL VENOUS CATHETER WAS INSERTED, AND NORADRENALINE WAS ADMINISTERED AT A DOSE OF 2.7 MG/HOUR. -NEUROLOGICAL CONDITION CONTINUED TO DETERIORATE, REQUIRING INTUBATION. PER SOURCE THIS LED TO SIGNIFICANT INHALATION OF HEMORRHAGIC GASTRIC FLUID AND FURTHER WORSENED THE CONDITION. THE SUBJECT WAS TRANSFERRED TO THE MEDICAL INTENSIVE CARE FOR TREATMENT OF THE HEMORRHAGIC SHOCK. ON ADMISSION TO INTENSIVE CARE, THE SUBJECT HAD SIGNS OF PERIPHERAL HYPOPERFUSION, MOTTLING, COLD EXTREMITIES, CARDIAC DECOMPENSATION SYMPTOMS, WITH SIGNIFICANT HYDRO-SODIUM OVERLOAD AND LEG SWELLING REACHING THE LUMBAR AREA. THE PERIPHERAL PULSES WERE NOT PALPABLE; HOWEVER, THE SUBJECT WAS STILL HYPOTENSIVE. HEART SOUNDS WERE REGULAR, WITH NO AUDIBLE MURMUR. THE SUBJECT CONTINUED TO BE ON NORADRENALINE AT 2.7 MG/HR. ELECTROCARDIOGRAM (ECG) SHOWED REGULAR SINUS RHYTHM WITH NO REPOLARIZATION DISORDER. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED PRESERVED LEFT VENTRICULAR EJECTION FRACTION (LVEF), TRANSMITRAL DOPPLER WITH RELAXATION DISORDERS, WITH E/E[?] < AT 8; SUBAORTIC VTI AT 18 CM FOR A HEART RATE AT 120 BPM; THE RIGHT CAVITIES WERE UNDILATED, WITH NO RIGHT VENTRICULAR DYSFUNCTION; TR WAS MEASURED AT 40 MMHG; DILATED INFERIOR VENA CAVA WERE SEEN WHICH WERE NON-COMPLIANT, AND NO PERICARDIAL EFFUSION WAS NOTED. THE SUBJECT WAS PLACED CONTROLLED VENTILATION, REQUIRING LITTLE OXYGEN AT 40% AND WITH NO BREATHING DIFFICULTY. AUSCULTATION REVEALED BILATERAL RHONCHI. THE ABDOMEN WAS DISTENDED, WITH SIGNIFICANT ASCITES AND A REDUCIBLE UMBILICAL HERNIA. THE SUBJECT WAS KEPT UNDER SEDATION WITH HYPNOVEL AND SUFENTANIL. THE PUPILS WERE BILATERALLY MIOTIC. CALCIUM GLUCONATE, VITAMIN K WERE ADMINISTERED TO THE SUBJECT. ADDITIONALLY, TWO PACKS OF FRESH FROZEN PLASMA AND ONE PLATELET CONCENTRATE PACK WAS TRANSFUSED AND LOW MOLECULAR WEIGHT HEPARIN REVERSAL BY PROTAMINE WAS UNDERTAKEN. EMERGENT ESOPHAGO-GASTRODUODENOSCOPY WAS ORDERED WITH ABDOMINAL COMPUTED TOMOGRAPHY (CT) IN VIEW OF THE INCREASED ABDOMINAL PERIMETER, WHICH SHOWED ASCITES IN HIGH ABUNDANCE, WITH NO INTRAPERITONEAL HEMORRHAGE; AN EXTENSION OF THE PORTAL VEIN THROMBOSIS WAS NOTED (INITIALLY TREATED WITH PREVISCAN AT A DOSE OF 3/4 CAPSULES PER DAY THEN WAS REPLACED WITH NEXAVAR), INVOLVING THE LEFT PORTAL BRANCH, THE RIGHT PORTAL BRANCH, THE PORTAL TRUNK, WITH RESULTANT LEFT-SIDE HEPATIC ISCHEMIA; ESOPHAGEAL VARICES, WITH NO SIGNS OF ACTIVE BLEEDING WERE SEEN. CHEST CT SCAN SHOWED FOCI OF BILATERAL LOWER LOBE CONSOLIDATION OF INFECTIOUS APPEARANCE, CONSISTENT WITH RIGHT LOWER LOBE AND RIGHT UPPER MIDDLE LOBE BRONCHOPNEUMONIA, WHICH, PER SOURCE, WAS PROBABLY SECONDARY TO INHALATION. ANTIBIOTIC THERAPY WITH CLAFORAN, METRONIDAZOLE AND AMIKLIN WAS INITIATED. FURTHER, FIBROSCOPY REVEALED ULCER OF THE SUPERIOR FLEXURE OF THE DUODENUM, WITH ARTERIOLAR BLEEDING. THE HEMORRHAGE WAS LATER TREATED WITH ADRENALINE AND WARM FORECEP COAGULATION. SEVERAL VULNERABLE AREAS WERE NOTICED WITH HEMORRHAGIC SUFFUSION, NOT OPERABLE OWING TO THE RISK OF PERFORATION AND INCREASING BLEEDING; ESOPHAGEAL VARICES WERE SEEN, INITIALLY WITH FEW RED WALE SIGNS, WITH NO ACTIVE BLEEDING. DESPITE ALL TREATMENT MEASURES AND OPTIMIZATION OF COAGULOPATHY, THE SUBJECT'S CLINICAL COURSE DETERIORATED WITH THE DEVELOPMENT OF MULTIVISCERAL FAILURE, REQUIRING NORADRENALINE UP TO 3G/KG/MIN. A ROTEM (ROTATIONAL THROMBO ELASTOMETRY) TEST WAS PERFORMED WHICH REVEALED CORRECTION OF THE COAGULATION DISORDER. METABOLIC ACIDOSIS AND HYPERLACTATEMIA PERSISTED, HYPERKALEMIA CONTROLLED BY TREATMENT. NO FURTHER THERAPEUTIC TREATMENT. DUE TO THE SUBJECT'S AGE AND COMORBIDITIES INCLUDING WORSENING CIRRHOSIS AND CONTINUING ALCOHOLISM WITH PALLIATIVE CARE FOR HEPATOCELLULAR CARCINOMA (HCC), PROGRESSING PVT AND AREAS OF HEPATIC ISCHEMIA, IT WAS DECIDED NOT TO IMPLEMENT FURTHER THERAPY. ONE DAY LATER, THE SUBJECT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659960 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW BIOCOMPATIBLES UK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death