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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BTG INTERNATIONAL/BIOCOMPATIBLES U. K. LIMITED THERASPHERE MICROSPHERES RADIONUCLIDE

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BTG INTERNATIONAL/BIOCOMPATIBLES U. K. LIMITED THERASPHERE MICROSPHERES RADIONUCLIDE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Hepatitis (1897); Tissue Damage (2104); Injury (2348); Radiation Exposure, Unintended (3164); Cancer (3262)
Event Date 04/15/2017
Event Type  Death  
Event Description
My mother, (b)(6), had right hepatic lobe hepatocellular carcinoma and received selective internal radiation therapy (sirt) with yttrium-90 microspheres via intra-arterial administration at (b)(6) hospital. On (b)(6) 2015, the physician dr. (b)(6), noted "radiation-induced liver disease, status post y-90 therasphere in (b)(6) 2015. " ths lead to her death within 6 months of the procedure. She would almost certainly have lived at least several years longer without this procedure. She was age (b)(6) and both grandmothers lived to age (b)(6), so this was an early death. She was in good health before this procedure other than the (b)(6) and suspected recurrence of liver cancer. Dr. (b)(6) reported on the procedure, "clinical information: (b)(6)-year-old female patient with right hepatic lobe hepatocellular carcinoma is referred for selective internal radiation therapy (sirt) with yttrium-90 microspheres via intra-arterial administration. Y-90 dosage was calculated from previously performed dosimetric diagnostic study using tc-99m maa as a surrogate for y-90 microspheres (see report dated (b)(6) 2015). Informed verbal and written consent was obtained from the patient following discussion of therapeutic options, including benefits, risks,radiation safety. Radiation dosimetry was calculated according to manufacturer's protocol: yttrium-90 microsphere dosage of 2. 27 gbq calculated to deliver 118 gy to targeted 895 cc right haptic lobe and 6 gy to lungs with 4. 3 percent lung shunt. " - more information: procedure: in the nuclear medicine family, the y-90 microsphere vial was inspected, activity measured and dosage approved for use by the authorized user. In the interventional radiology suite, sirt delivery system was set up and loaded with y-90 microspheres according to manufacturer's specifications under the direct supervision of the medical radiation physicist, dr. (b)(6). After verification of predetermined location for placement of the intra-hepatic artery catheter and connection to the sirt delivery system, y-90 microspheres were infused into the liver according to protocol without any adverse events. The catheter was removed without incident. Radiation exposure rate from the patient at one meter was measured, 0. 8 mr/hr. The room and personnel surveyed according to protocol and there was no evidence of radiation spillage or contamination. Radioactive waste was collected, placed in a plastic jar and returned to nuclear medicine for measurement and storage/disposal. Confirmation of administrated dose: the residual radioactive waste contained in the plastic jar was measured at 30 cm and the residual dosage was subtracted from identically measured pretreated dosage of y-90. Net delivered dosage to the patient, 2. 15 gbq; delivered radiation dose, based on prior dosimetry study, to the targeted liver, 112 gy; to the lungs, 4. 6 gy. Ref mfr report # 3002124545-2017-00001.
 
Event Description
Add'l info received from reporter on 05/03/2017 for mw5069194. When i informed prof dr. (b)(6) of my mother's death from therasphere due to rild (radiation-induced liver disease) he responded to me by email on 04/15/2017, "unfortunately hepatocellular cancer is not curable and we observed this course you described quite often. " this leads me to believe that there have been multiple deaths from "therasphere rild at his facility. Like my mother's facility - (b)(6), his facility does not have a clinical trial, but rather is considered a therasphere treatment facility. This is his contact info: (b)(6). Tests on my mother were already reported - (mdr report key (b)(4), report number 3002124545-2017-00001) i do not access to data on any tests performed at (b)(6). This is the info i provided dr. (b)(6): "i saw on the (b)(6), therasphere trials website that your facility has a therasphere treatment center. I am writing to inform you of another case study that could serve to aid in screening pts for this procedure when it is being targeted to the liver. My mother, (b)(6) which after many years resulted in liver cancer. She had the therasphere procedure performed at the (b)(6) treatment center in 2015 and died within six months from radiation-induced liver disease. She had y 90 therasphere on (b)(6) 2015 and died on (b)(6) 2015. There does not appear to be a centralized place to disseminate this info (she was no port of an nih clinical trial) and i'm sure you could benefit from this add'l info in screening your pts for the procedure. I have reported this finding to (b)(6). However, but it does not appear that there is a mechanism there or at nih to notify treatment centers of fatal outcomes that occur outside of established clinical trials. My mother had a history of low sodium and low albumin. I believe that pts with low sodium are not good candidates for therasphere targeted to the liver because if the liver is further damaged. They will not be able to tolerate the diuretics necessary to control the ascites. ".
 
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Brand NameTHERASPHERE
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BTG INTERNATIONAL/BIOCOMPATIBLES U. K. LIMITED
MDR Report Key6507084
MDR Text Key73366053
Report NumberMW5069194
Device Sequence Number1
Product Code NAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/18/2017 Patient Sequence Number: 1
Treatment
(CALCIUM-VITAMIN D 600 MG - 200 INTL UNITS ORAL ; 1 CAP, BY MOUTH, TWICE DAILY.; BEFORE BEDTIME. ; BY MOUTH, DAILY.; CAPSULE) 1 CAP, BY MOUTH.; DAILY MULTIVITAMIN WITH MINERALS (MULTIVITAMIN; DAILY, TAKE 2-3 TABS DAILY AT NIGHT 1 TO 3 HOURS; GABAPENTIN (GABAPENTIN 300 MG ORAL CAPSULE), ; LORATADINE (LORATADINE 10 MG ORAL TABLET) 1 TAB, ; NEEDED.; OMEPRAZOLE (OMEPRAZOLE 20 MG ORAL TABLET, EXTENDED; ORAL TABLET) 1 TAB, BY MOUTH, DAILY.; OTC MEDS: CALCIUM AND VITAMIN D COMBINATION ; PSEUDOEPHEDRINE 25 MG, BY MOUTH, DAILY, PM AS ; RELEASE) 1 TAB, BY MOUTH, DAILY.; ROPINIROLE (ROPINIROLE 2 MG ORAL TABLET), BY MOUTH; RX MEDS: CONJUGATED ESTROGENS (PREMARIN 0.625 MG; WITH MINERALSS ORAL TABLET) 1 TAB, BY MOUTH, DAILY
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