FDA Adverse Event Death Summary report: N

THERASPHERE

MDR report key: 2780084 · Received October 10, 2012

Report

Report Number
2780084
Event Type
Death
Date Received
October 10, 2012
Date of Event
September 10, 2012
Report Date
September 25, 2012
Manufacturer
MDS NORDION
Product Code
NAW
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MD, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT (B)(6) WAS A (B)(6) MALE DIAGNOSED (B)(6) 2012, WITH A MODERATELY DIFFERENTIATED ADENOCARCINOMA ORIGINALLY FOUND AS A MASS IN THE ESOPHAGUS WITH INNUMERABLE LIVER LESIONS. HE WAS TREATED AT (B)(6) WITH SYSTEMIC CHEMOTHERAPY IN (B)(6) 2012, WITH DOCETAXEL, OXALIPLATIN, AND FLUOROURACIL. HE ALSO ELECTED TO SEEK CARE FROM VARIOUS INSTITUTIONS WITH MANY OF THESE CATERING TO A HOLISTIC APPROACH. HE WAS FIRST EVALUATED AT (B)(6) IN MULTI-DISCIPLINARY LIVER CONFERENCE, (B)(6) 2012 AND SYSTEMIC AND LOCAL REGIONAL TREATMENT OPTIONS WERE DISCUSSED BY DRS (B)(6). CONTINUING SYSTEMIC TREATMENT WAS RECOMMENDED, FIRST, AND LOCAL REGIONAL TREATMENT, USING THERASPHERE Y90 RADIOEMBOLIZATION, WAS PROVIDED AS AN OPTION, SHOULD HE HAVE PROGRESSION OF HIS LIVER METASTASES. HE RECEIVED SYSTEMIC THERAPY LOCALLY AND THEN DECIDED TO STOP THAT THERAPY AND RECEIVE ALTERNATIVE TREATMENT WITH LAETRILE AND OTHER HOLISTIC ALTERNATIVES. NOTES INDICATE THAT HE ALSO WAS TREATED WITH DMSO FOR APPROX 40 DAYS INTRAVENOUSLY. (DIMETHYL SULFOXIDE, OR DMSO, IS AN INDUSTRIAL SOLVENT THAT IS A BY-PRODUCT OF MAKING PAPER. IT HAS BEEN PROMOTED AS AN ALTERNATIVE CANCER TREATMENT SINCE THE 1960'S.) THIS TREATMENT ENDED IN (B)(6) 2012. MR CG RETURNED TO CLINIC (B)(6) 2012, NOTING THAT HE HAD JUST STARTED TO DEVELOP ABDOMINAL PAIN OVER THE FEW DAYS BEFORE. HE RATED IT AT ONLY 02/10 AND HIS ECOG WAS 1. HE UNDERWENT A SHUNT STUDY (B)(6) 2012. HIS TUMOR VOLUMES WERE A TOTAL OF 60% OF HIS LIVER, HOWEVER, TUMOR VOLUME UNDER 70% IS PERMISSIBLE UNDER THE ELIGIBILITY CRITERIA AND HIS SHUNT FRACTION WAS FAVORABLE AT 3.9%. HE RETURNED (B)(6) 2012, FOR TREATMENT OF THE RIGHT HEPATIC LOBE. HE NOTED HIS PAIN HAD INCREASED TO 3/10, BUT HIS ECOG REMAINED 1. HE WAS TREATED WITH 112.4 GY TO THE RIGHT HEPATIC LOBE. HE TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED WITHOUT INCIDENT. HE WAS CALLED FOR F/U (B)(6) 2012 AND ALTHOUGH HE HAD A "ROUGH TIME" WITH FATIGUE AND ABDOMINAL PAIN, HE WAS FEELING BETTER AND HAD STOPPED TAKING ALEVE, FOR PAIN. ON (B)(6) 2012, MRS (B)(6) CALLED TO REPORT THAT HER HUSBAND HAD SIGNIFICANT BILATERAL LE EDEMA AND THEY WERE BOARDING THE PLANE FROM A TRIP TO (B)(6). WE RECOMMENDED HE SEE HIS PCP WHEN THEY ARRIVED HOME TO GET LABS AND EVALUATION. MRS (B)(6) CALLED AGAIN (B)(6) 2012, FROM AN "ENVIRONMENTAL HEALTH" CLINIC WHERE THEY TEST FOR "TOXICITIES". (B)(6) WAS WAITING TO SEE DR (B)(6). THE PREVIOUS TWO DAYS HE HAD RECEIVED LASIX AND OXYGEN TREATMENTS, BUT WAS STILL HAVING SOME SHORTNESS OF BREATH. THE PT'S WIFE SAID HIS BILIRUBIN WAS 1.8 AND SODIUM AND CHLORIDE WERE LOW. HIS CREATININE WAS 0.7. SHE WAS CONCERNED THAT HE MAY NEED TO BE ADMITTED. WE RECOMMENDED WAITING TO SEE WHAT DR (B)(6) RECOMMENDED. MRS (B)(6) CALLED TO INFORM US LATER THAT HE WAS DIAGNOSED WITH A RLE DVT AND WAS PUT ON COUMADIN 7.5 MG ALTERNATING WITH 5 MG. THEY REQUESTED AN MRI REQUISITION FOR THE F/U MRI SINCE THEY COULD NOT MAKE THE TRIP TO (B)(6) FOR F/U CLINIC, LABS AND MRI. WHEN HE WAS CALLED (B)(6) 2012, MRS (B)(6) NOTED HE WAS BEING ADMITTED TO (B)(6) FOR ASCITES AND PARACENTESIS. HIS RECORDS WERE REQUESTED FROM (B)(6) HOSPITAL (B)(6) 2012. A VOICEMAIL WAS LEFT FRIDAY, (B)(6) 2012, BY MRS (B)(6) STATING THAT (B)(6) WAS ADMITTED, "A FEW DAYS AGO", TO (B)(6). SHE REQUESTED THE CT SCAN FROM PRE-RADIOEMBOLIZATION SO THEY COULD COMPARE TO THE CT RECENTLY OBTAINED AT (B)(6). WHEN THE PHONE CALL WAS RETURNED MONDAY, (B)(6) 2012, MRS (B)(6)'S MOTHER ANSWERED AND WE WERE INFORMED THAT (B)(6) HAD DIED EARLIER THAT MORNING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 THERASPHERE Y90 RADIOEMBOLIZATION NAW MDS NORDION

Patients

Seq Age Sex Outcome Treatment
1 55 YR Death| H MOUTH 2 PER DAY| PANCREATIN (ENZYMES) PROPRIETARY BLEND BY| SELENIUM 200 MG BY MOUTH 1 PER DAY| GLUCARATE 48 MG, GLUCARATE 400 MG BY MOUTH 2/DAY| COQ10 200 MG BY MOUTH 2 TIMES PER DAY| 48 HRS BEFORE TREATMENT AND PLANNED TO ABSTAIN| BUT STATED HE HAD NOT TAKEN ANY OF THESE IN THE| BROMELAIN 500 MG BY MOUTH 2 PER DAY| GREENZONE POWDER 1 TBL| NATTOKINASE-NATTO EXTRACT 100 MG 2000 FU BY MOUTH| LIQUID CHLOROPHYLL 1 TBL| VITAMIN D3 5000 INTL UNITS BY MOUTH 1 TIME PER DAY| 1 PER DAY| RUBY RED 1 TBL| LIVER CARE HERBAL BLEND 375 MG BY MOUTH 2 PILLS/DA| FROM THEM UNTIL 72 HRS POST PROCEDURE ((B)(6)2012)| CALCIUM 750 MG BY MOUTH 2-3 TIMES PER DAY| VITAMIN C WITH ROSE HIPS 1000 MG BY MOUTH 1/DAY| MEDICATION WAS RECOMMENDED TO STOP SECONDARY| TO THE BYPRODUCTS OF CYANIDE) 500 MG BY MOUTH| LIPOIC ACID (ALPHA-LIPOIC ACID) 300 MG BY MOUTH| SILYMARIN 210 MG BY MOUTH 2 PER DAY| PROVELAIN IODINE 20 MG BY MOUTH 1 PER DAY| MAGNESIUM 400 MG TWO PER DAY| FLAXSEED OIL EXTRACT 2000 MG BY MOUTH 3 PER DAY| THE PT WAS ON THE FOLLOWING MEDICATIONS| MOUTH 2 PER DAY| AMYGDALIN B17 ALSO CALLED LAETRILE (THIS| VITAMIN E 400 MG BY MOUTH 1 PER DAY| DRENAMIN NIACIN 12 MG BY MOUTH 3 PER DAY| TRIGGER IMMUNE HERBAL BLEND ROOTS 470 MG BY| PROACTAZYME (ENZUMES) 45 MG BY MOUTH 4 PER DAY| 4-6 PER DAY| SUPER ALGAE 1233 MG PER PROPRIETARY BLEND| TB8 (PROBIOTIC) 14B BY MOUTH 4 PER DAY| SALMON OIL 1000 MG BY MOUTH 4 PER DAY| BSHERS WITHOUT B6 (BLEND BY MOUTH 1 PER DAY)| ORALLY 6 PILLS PER DAY| 2 PER DAY