BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 5056672 · Received September 2, 2015

    Report

    Report Number
    3002124545-2015-00060
    Event Type
    Death
    Date Received
    September 2, 2015
    Date of Event
    July 11, 2015
    Report Date
    August 10, 2015
    Manufacturer
    BICI OTTAWA OFFICE
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    COMPANY COMMENT: THE EVENTS OF HEMORRHAGIC SHOCK (FATAL), PULSELESS ELECTRICAL ACTIVITY (HOSPITALIZATION), ACUTE RESPIRATORY FAILURE (MEDICALLY SIGNIFICANT), SEPTIC SHOCK (HOSPITALIZATION), SPONTANEOUS BACTERIAL PERITONITIS (HOSPITALIZATION), ACUTE KIDNEY INJURY (MEDICALLY SIGNIFICANT), HAEMORRHAGIC ANAEMIA (MEDICALLY SIGNIFICANT), ENCEPHALOPATHY (MEDICALLY SIGNIFICANT), BRAIN INJURY (MEDICALLY SIGNIFICANT), LACTIC ACIDOSIS (MEDICALLY SIGNIFICANT), HEMATEMESIS (HOSPITALIZATION) AND DISSEMINATED INTRAVASCULAR COAGULATION (HOSPITALIZATION) ARE CONSIDERED UNLISTED ACCORDING TO THE THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. THE COMPANY CONSIDERS THE EVENTS OF HEMORRHAGIC SHOCK, PULSELESS ELECTRICAL ACTIVITY, SPONTANEOUS BACTERIAL PERITONITIS, SEPTIC SHOCK, ACUTE RESPIRATORY FAILURE, ACUTE KIDNEY INJURY, HEMORRHAGIC ANAEMIA, ACUTE ENCEPHALOPATHY, ANOXIC BRAIN INJURY, HEMATEMESIS, AND DISSEMINATED INTRAVASCULAR COAGULATION AS NOT RELATED TO THE USE OF THERASPHERE. THE PATIENT'S MEDICAL HISTORY OF HEPATOCELLULAR CARCINOMA AND CIRRHOSIS PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE OF THE POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS WHICH PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE OF THE POSSIBLE SEPTIC SHOCK. THE EVENT OF SEPTIC SHOCK PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE OF THE POSSIBLE DISSEMINATED INTRAVASCULAR COAGULATION. THE EVENTS OF THE POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS AND DISSEMINATED INTRAVASCULAR COAGULATION PROVIDES ALTERNATIVE EXPLANATIONS AS A CONTRIBUTING FACTOR FOR THE HEMORRHAGIC SHOCK, HEMORRHAGIC ANAEMIA, AND HEMATEMESIS. THE EVENT OF HEMORRHAGIC SHOCK WITH THE HEMORRHAGIC ANEMIA PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE THE PULSELESS ELECTRICAL ACTIVITY, ACUTE RESPIRATORY FAILURE AND ACUTE KIDNEY INJURY. THE EVENT OF PULSELESS ELECTRICAL ACTIVITY PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE FOR LACTIC ACIDOSIS AND ANOXIC BRAIN INJURY WHICH PROVIDES AN ALTERNATIVE EXPLANATION AS THE CAUSE OF THE ACUTE ENCEPHALOPATHY. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF THERASPHERE. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS. FOLLOW-UP INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    PATIENT EXPIRED FROM HEMORRHAGIC SHOCK [SHOCK HAEMORRHAGIC], PULSELESS ELECTRICAL ACTIVITY ARREST, ACUTE RESPIRATORY FAILURE, POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS, POSSIBLE SEPTIC SHOCK VS HYPOVOLEMIC SHOCK [SEPTIC SHOCK], DISSEMINATED INTRAVASCULAR COAGULATION, ACUTE BLOOD LOSS ANEMIA [HAEMORRHAGIC ANAEMIA] SEVERE ANOXIC BRAIN INJURY [BRAIN INJURY], ACUTE ENCEPHALOPATHY [ENCEPHALOPATHY], LACTIC ACIDOSIS, ACUTE RENAL FAILURE [ACUTE KIDNEY INJURY], HEMATEMESIS. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 10-AUG-2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL CONCERNING A (B)(6) MALE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED HEPATOCELLULAR CARCINOMA, (B)(6), CIRRHOSIS, ASCITES, CONGESTIVE HEART FAILURE WITH A HISTORY OF INTRAVENOUS DRUG ABUSE, AND DIAGNOSTIC LAPAROTOMY WITH CORE BIOPSY OF THE LIVER SEGMENT VIII IN (B)(6) 2015. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS PRIOR TO THE TIME OF THE EVENT. THE PATIENT RECEIVED THERASPHERE (LOT NUMBER AND EXPIRATION DATE UNKNOWN) ON AN UNSPECIFIED DATE. ON (B)(6) 2015, THE PATIENT DEVELOPED WEAKNESS, ABDOMINAL PAIN, INCREASED ABDOMINAL SWELLING AND HEMATEMESIS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY TRANSPORT SYSTEM. IN THE EMERGENCY ROOM, HE WAS INITIALLY STABLE BUT WITH A TEMPERATURE OF 94.5. OTHER LABORATORY VALUES INCLUDED: WHITE BLOOD CELL COUNT (WBC) 6.9; HEMOGLOBIN 6.8; PLATELET COUNT 49,000 (WHICH IS UP FROM 19000 A FEW DAYS PRIOR); SODIUM 135; POTASSIUM 6.0; CHLORIDE 108; CARBON DIOXIDE (CO2) 6; CREATININE 2.7 (FROM A BASELINE OF 1.3); GLUCOSE 26; CALCIUM 8.0; MAGNESIUM 2.7; PHOSPHORUS 5.3; ALBUMIN 1.6; ASPARTATE AMINOTRANSFERASE (AST) 288; ALANINE AMINOTRANSFERASE (ALT) 119; INTERNATIONAL NORMALISED RATIO (INR) 2.7, TOTAL BILIRUBIN 2.8; ALCOHOL LEVEL NEGATIVE, ALKALINE PHOSPHATASE 111; AND ARTERIAL PH LESS THAN 6.7. THE PATIENT EXPERIENCED AN EPISODE OF COFFEE-GROUND EMESIS, AND A SHORT TIME LATER EXPERIENCED A 20 MINUTE EPISODE OF PULSELESS ELECTRICAL ACTIVITY (PEA). THE RESUSCITATIVE MEASURES INCLUDED: INTUBATION WITH VENTILATION FOR ACUTE RESPIRATORY FAILURE; 4 DOSES OF EPINEPHRINE; BROAD SPECTRUM ANTIBIOTICS VANCOMYCIN, ZOSYN (PIPERACILLIN/TAZOBACTAM), CIPRO (CIPROFLOXACIN); 2 LITERS NORMAL SALINE; 5 AMPULES OF SODIUM BICARBONATE; 2 AMPULES OF ATROPINE; 2 DOSES OF DIPRIVAN (PROPOFOL); KAYEXALATE (SODIUM POLYSTYRENE SULFONATE); INTRAVENOUS DRIPS OF LEVOPHED (NOREPINEPHRINE), SODIUM BICARBONATE AND PROTONIX (PANTOPRAZOLE); ATIVAN (LORAZEPAM); CALCIUM CHLORIDE; 2 UNITS OF PACKED RED BLOOD CELLS (PRBC); AND 4 UNITS OF FRESH FROZEN PLASMA (FFP). THE DIFFERENTIAL DIAGNOSIS INCLUDED SEPTIC VERSUS HYPOVOLEMIC SHOCK WITH A POSSIBLE SOURCE OF SEPTIC SHOCK AS SPONTANEOUS BACTERIAL PERITONITIS. AFTER THE PATIENT RETURNED TO SPONTANEOUS CIRCULATION, HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS IN HEMORRHAGIC SHOCK WITH DISSEMINATED INTRAVASCULAR COAGULATION, AND WAS HEMORRHAGING FROM ALL ORIFICES, NASOGASTRIC TUBE AND NEEDLE STICK SITES. IN THE ICU, THE PATIENT'S ABDOMEN BECAME ACUTELY MORE DISTENDED. ADDITIONAL DIAGNOSIS INCLUDED ACUTE BLOOD LOSS ANEMIA, ACUTE RENAL FAILURE, SEVERE ANOXIC BRAIN INJURY WITH THE EXTENDED EPISODE OF PEA, ACUTE ENCEPHALOPATHY AND LACTIC ACIDOSIS. AN INITIAL ICU ARTERIAL BLOOD GAS (ABG) HAD A PH OF 6.8 AND LACTIC ACID OF 21. THE PATIENT'S PUPILS WERE 7 MM AND MINIMALLY REACTIVE. OTHER PHYSICAL EXAM FINDINGS IN THE ICU INCLUDED: +1 TO +2 PITTING EDEMA; DIFFUSE WHEEZES IN ALL LUNG FIELDS; PROTUBERANT ABDOMEN WITHOUT A FLUID WAVE BUT A FEW BOWEL SOUNDS TO AUSCULTATION; AND UNRESPONSIVE TO DEEP AND PAINFUL STIMULI. CONTINUED RESUSCITATIVE THERAPIES INCLUDED MAXIMUM DOSES OF VASOPRESSIN AND NEO-SYNEPHRINE (PHENYLEPHRINE HYDROCHLORIDE), LEVOPHED (NOREPINEPHRINE), SODIUM BICARBONATE 4 ADDITIONAL UNITS OF FFP, 2 UNITS OF CRYOPRECIPITATE AND 6 ADDITIONAL UNITS OF PRBC. AFTER 3 HOURS OF AGGRESSIVE SUPPORTIVE MEASURES IN THE INTENSIVE CARE, A DO NOT RESUSCITATE ORDER WAS PUT IN PLACE. THE PATIENT WAS SWITCHED TO SUPPORTIVE CARE AWAITING THE ARRIVAL OF HIS SON. SUPPORTIVE MEASURES INCLUDED ADDITIONAL DOSES OF SODIUM BICARBONATE AND FLUID BOLUSES FOR HYPOTENSION. THE PATIENT'S STATUS CONTINUED TO DETERIORATE WITH ARTERIAL PRESSURES BELOW 60 SYSTOLIC CONSISTENTLY. THE PATIENT BECAME ASYSTOLIC AND EXPIRED ON (B)(6) 2015 AT 12:50 AM. THE REPORTED CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND WAS NOT RELATED TO THERASPHERE BUT RELATED TO THE PATIENT'S UNDERLYING CIRRHOSIS. THE HEALTHCARE PROFESSIONAL ASSESSED THE EVENTS OF HEMORRHAGIC SHOCK, DISSEMINATED INTRAVASCULAR COAGULATION AND ANOXIC BRAIN INJURY TO BE UNRELATED TO THE USE OF THE THERASPHERE. THE HEALTHCARE PROFESSIONAL'S CAUSALITY ASSESSMENTS FOR THE EVENTS OF PULSELESS ELECTRICAL ACTIVITY, ACUTE RESPIRATORY FAILURE, ACUTE KIDNEY INJURY, HEMORRHAGIC ANEMIA, ENCEPHALOPATHY, HEMATEMESIS, POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS, POSSIBLE SEPTIC SHOCK VS HYPOVOLEMIC SHOCK TO SEPTIC SHOCK, AND LACTIC ACIDOSIS WERE NOT REPORTED. FOLLOW-UP INFORMATION IS EXPECTED. FOLLOW-UP INFORMATION RECEIVED ON 31-AUG-2015: FOLLOW-UP INFORMATION WAS PROVIDED BY THE PHYSICIAN WHO INITIALLY REPORTED THE CASE. THE PATIENT HAD A RELEVANT MEDICAL HISTORY WHICH INCLUDED PANCYTOPENIA, GASTROINTESTINAL BLEED DUE TO A DUODENAL ULCER IN 2006 BUT NO HISTORY OF ESOPHAGEAL VARICES. THE INITIAL CAUSE OF THE HEMORRHAGE WAS PROVIDED AS HEMATEMESIS. THE PATIENT WAS DIAGNOSED WITH HEMORRHAGIC SHOCK WITH THE ADDITIONAL DIAGNOSIS OF ACUTE BLOOD LOSS ANEMIA. THE SERIAL NUMBER FOR THERASPHERE WAS (B)(4) AND WAS IMPLANTED ON (B)(6) 2015. THE PHYSICIAN STATED THAT THE EVENTS WERE RELATED TO THE PATIENT'S SEVERE CIRRHOSIS. CASE COMMENT: THE EVENTS OF HEMORRHAGIC SHOCK (FATAL), PULSELESS ELECTRICAL ACTIVITY (HOSPITALIZATION), ACUTE RESPIRATORY FAILURE (MEDICALLY SIGNIFICANT), SEPTIC SHOCK (HOSPITALIZATION), SPONTANEOUS BACTERIAL PERITONITIS (HOSPITALIZATION), ACUTE KIDNEY INJURY (MEDICALLY SIGNIFICANT), HAEMORRHAGIC ANAEMIA (MEDICALLY SIGNIFICANT), ENCEPHALOPATHY (MEDICALLY SIGNIFICANT), BRAIN INJURY (MEDICALLY SIGNIFICANT), LACTIC ACIDOSIS (MEDICALLY SIGNIFICANT), HEMATEMESIS (HOSPITALIZATION) AND DISSEMINATED INTRAVASCULAR COAGULATION (HOSPITALIZATION) ARE CONSIDERED UNLISTED ACCORDING TO THE THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. THE COMPANY CONSIDERS THE EVENTS OF HEMORRHAGIC SHOCK, PULSELESS ELECTRICAL ACTIVITY, SPONTANEOUS BACTERIAL PERITONITIS, SEPTIC SHOCK, ACUTE RESPIRATORY FAILURE, ACUTE KIDNEY INJURY, HEMORRHAGIC ANAEMIA, ACUTE ENCEPHALOPATHY, ANOXIC BRAIN INJURY, HEMATEMESIS, AND DISSEMINATED INTRAVASCULAR COAGULATION AS NOT RELATED TO THE USE OF THERASPHERE. THE COMPANY DOES NOT CONSIDER THIS RELATED TO THERASPHERE BECAUSE THE ADMINISTRATION OCCURRED FIVE WEEKS PRIOR TO THE EVENTS, THEREFORE THE MOST LIKELY EXPLANATION IS PROGRESSION OF UNDERLYING DISEASE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF THERASPHERE. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.

    Description of Event or Problem · 1

    PATIENT EXPIRED FROM HEMORRHAGIC SHOCK [SHOCK HAEMORRHAGIC] PULSELESS ELECTRICAL ACTIVITY ARREST [PULSELESS ELECTRICAL ACTIVITY]. ACUTE RESPIRATORY FAILURE [ACUTE RESPIRATORY FAILURE]. POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS [PERITONITIS BACTERIAL]. POSSIBLE SEPTIC SHOCK AND HYPOVOLEMIC SHOCK [SEPTIC SHOCK] DISSEMINATED INTRAVASCULAR COAGULATION [DISSEMINATED INTRAVASCULAR COAGULATION]. ACUTE BLOOD LOSS ANEMIA [HAEMORRHAGIC ANAEMIA]. SEVERE ANOXIC BRAIN INJURY [BRAIN INJURY]. ACUTE ENCEPHALOPATHY [ENCEPHALOPATHY]. LACTIC ACIDOSIS [LACTIC ACIDOSIS]. ACUTE RENAL FAILURE [ACUTE KIDNEY INJURY]. HEMATEMESIS [HAEMATEMESIS]. CASE DESCRIPTION: INITIAL INFO RECEIVED ON AUGUST 10, 2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL CONCERNING A (B)(6) AFRICAN-AMERICAN MALE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED HEPATOCELLULAR CARCINOMA, HEPATITIS C, CIRRHOSIS, ASCITES, CONGESTIVE HEART FAILURE WITH A HISTORY OF INTRAVENOUS DRUG ABUSE, AND DIAGNOSTIC LAPAROTOMY WITH CORE BIOPSY OF THE LIVER SEGMENT VIII IN (B)(6) 2015. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS PRIOR TO THE TIME OF THE EVENT. THE PATIENT RECEIVED THERASPHERE (LOT NUMBER AND EXPIRATION DATE UNKNOWN) ON AN UNSPECIFIED DATE. ON (B)(6) 2015, THE PATIENT DEVELOPED WEAKNESS, ABDOMINAL PAIN, INCREASED ABDOMINAL SWELLING AND HEMATEMESIS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY TRANSPORT SYSTEM. IN THE EMERGENCY ROOM, HE WAS INITIALLY STABLE BUT WITH A TEMPERATURE OF 94.5. OTHER LABORATORY VALUES INCLUDED: WHITE BLOOD CELL COUNT (WBC) 6.9; HEMOGLOBIN 6.8; PLATELET COUNT 49,000 (WHICH IS UP FROM 19000 A FEW DAYS PRIOR); SODIUM 135; POTASSIUM 6.0; CHLORIDE 108; CARBON DIOXIDE (C02) 6; CREATININE 2.7 (FROM A BASELINE OF 1.3); GLUCOSE 26; CALCIUM 8.0; MAGNESIUM 2.7; PHOSPHORUS 5.3; ALBUMIN 1.6; ASPARTATE AMINOTRANSFERASE (AST) 288; ALANINE AMINOTRANSFERASE (ALT) 119; INTERNATIONAL NORMALISED RATIO (INR) 2.7, TOTAL BILIRUBIN 2.8; ALCOHOL LEVEL NEGATIVE, ALKALINE PHOSPHATASE 111; AND ARTERIAL PH LESS THAN 6.7. THE PATIENT EXPERIENCED AN EPISODE OF COFFEE-GROUND EMESIS, AND A SHORT TIME LATER EXPERIENCED A 20 MINUTE EPISODE OF PULSELESS ELECTRICAL ACTIVITY (PEA). THE RESUSCITATIVE MEASURES INCLUDED: INTUBATION WITH VENTILATION FOR ACUTE RESPIRATORY FAILURE; 4 DOSES OF EPINEPHRINE; BROAD SPECTRUM ANTIBIOTICS VANCOMYCIN, ZOSYN (PIPERACILLIN/TAZOBACTAM), CIPRO (CIPROFLOXACIN); 2 LITERS NORMAL SALINE; 5 AMPULES OF SODIUM BICARBONATE; 2 AMPULES OF ATROPINE; 2 DOSES OF DIPRIVAN (PROPOFOL); KAYEXALATE (SODIUM POLYSTYRENE SULFONATE); INTRAVENOUS DRIPS OF LEVOPHED (NOREPINEPHRINE), SODIUM BICARBONATE AND PROTONIX (PANTOPRAZOLE); ATIVAN (LORAZEPAM); CALCIUM CHLORIDE; 2 UNITS OF PACKED RED BLOOD CELLS (PRBC); AND 4 UNITS OF FRESH FROZEN PLASMA (FFP). THE DIFFERENTIAL DIAGNOSIS INCLUDED SEPTIC VERSUS HYPOVOLEMIC SHOCK WITH A POSSIBLE SOURCE OF SEPTIC SHOCK AS SPONTANEOUS BACTERIAL PERITONITIS. AFTER THE PATIENT RETURNED TO SPONTANEOUS CIRCULATION, HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS IN HEMORRHAGIC SHOCK WITH DISSEMINATED INTRAVASCULAR COAGULATION, AND WAS HEMORRHAGING FROM ALL ORIFICES, NASOGASTRIC TUBE AND NEEDLE STICK SITES. IN THE ICU, THE PATIENT'S ABDOMEN BECAME ACUTELY MORE DISTENDED. ADDITIONAL DIAGNOSIS INCLUDED ACUTE BLOOD LOSS ANEMIA, ACUTE RENAL FAILURE, SEVERE ANOXIC BRAIN INJURY WITH THE EXTENDED EPISODE OF PEA, ACUTE ENCEPHALOPATHY AND LACTIC ACIDOSIS. AN INITIAL ICU ARTERIAL BLOOD GAS (ABG) HAD A PH OF 6.8 AND LACTIC ACID OF 21. THE PATIENT'S PUPILS WERE 7 MM AND MINIMALLY REACTIVE. OTHER PHYSICAL EXAM FINDINGS IN THE ICU INCLUDED: +1 TO +2 PITTING EDEMA; DIFFUSE WHEEZES IN ALL LUNG FIELDS; PROTUBERANT ABDOMEN WITHOUT A FLUID WAVE BUT A FEW BOWEL SOUNDS TO AUSCULTATION; AND UNRESPONSIVE TO DEEP AND PAINFUL STIMULI. CONTINUED RE-SUSCITATIVE THERAPIES INCLUDED MAXIMUM DOSES OF VASOPRESSIN AND NEE-SYNEPHRINE (PHENYLEPHRINE HYDROCHLORIDE), LEVOPHED (NOREPINEPHRINE), SODIUM BICARBONATE 4 ADDITIONAL UNITS OF FFP, 2 UNITS OF CRYOPRECIPITATE AND 6 ADDITIONAL UNITS OF PRBC. AFTER 3 HOURS OF AGGRESSIVE SUPPORTIVE MEASURES IN THE INTENSIVE CARE, A DO NOT RESUSCITATE ORDER WAS PUT IN PLACE. THE PATIENT WAS SWITCHED TO SUPPORTIVE CARE AWAITING THE ARRIVAL OF HIS SON. SUPPORTIVE MEASURES INCLUDED ADDITIONAL DOSES OF SODIUM BICARBONATE AND FLUID BOLUSES FOR HYPOTENSION. THE PATIENT'S STATUS CONTINUED TO DETERIORATE WITH ARTERIAL PRESSURES BELOW 60 SYSTOLIC CONSISTENTLY. THE PATIENT BECAME ASYSTOLIC AND EXPIRED ON (B)(6) 2015 AT 12:50 AM. THE REPORTED CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND WAS NOT RELATED TO THERASPHERE BUT RELATED TO THE PATIENT'S UNDERLYING CIRRHOSIS. THE HEALTHCARE PROFESSIONAL ASSESSED THE EVENTS OF HEMORRHAGIC SHOCK, DISSEMINATED INTRAVASCULAR COAGULATION AND ANOXIC BRAIN INJURY TO BE UNRELATED TO THE USE OF THE THERASPHERE. THE HEALTHCARE PROFESSIONAL'S CAUSALITY ASSESSMENTS FOR THE EVENTS OF PULSELESS ELECTRICAL ACTIVITY, ACUTE RESPIRATORY FAILURE, ACUTE KIDNEY INJURY, HEMORRHAGIC ANEMIA, ENCEPHALOPATHY, HEMATEMESIS, POSSIBLE SPONTANEOUS BACTERIAL PERITONITIS, POSSIBLE SEPTIC SHOCK AND HYPOVOLEMIC SHOCK TO SEPTIC SHOCK, AND LACTIC ACIDOSIS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582981 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW BICI OTTAWA OFFICE 1599124-108

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| O