MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-05-29 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[146335064]
The events were reported through a retrospective clinical trial. The events are considered serious due to hospitalization and related to therasphere administration. Btg medical assessment: subject (b)(6) is (b)(6) year-old male patient. Diagnosed with hcc on (b)(6) 2015. Presence of portal hypertension, bilobar tumor, bclc b, index tumor of 44 mm of the right liver. Etiologic associations: liver cirrhosis, alcoholic cirrhosis, no prior sorafenib treatment before therasphere and no disease specific surgery. Patient was treated with therasphere: (b)(6) 2015, infused in the right artery. Activity at start of infusion 3. 01 gbq; residuals remaining 0. 09gbq; lung shunt fraction 7. 4%; treatment to right lobe; 2nd treatment to left lobe on (b)(6) 2015; 2nd absorbed dose to the perfused volume 176. 4gy. Patient received the second treatment, the liver function has degradated compared to study entry: albumin 26g/l, bilirubin 2,3 mg. Lymphopenia is a common consequence of ts treatment. Patient experienced a reild, that associates the clinical symptoms of both ascites or increasing abdominal girth and jaundice or hyperbilirubinemia. Reild is the consequence of obstruction of the sinusoid as an effect of radiation that cause portal hypertension and cholestasis. Dose to the normal liver was above the ifu recommendation which is 80-150 gy to the whole liver and the patient received : 223 right liver and 176 gy left liver consequently, for the current situation, the patient might have experienced a reild that caused liver dysfunction and therefore renal dysfunction. All events are anticipated adverse events listed in the risk management documentation/ifu. No device malfunction was reported and no corrective and preventive action (capa) plan has been identified. The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed. Additional information has also been sought regarding hospital admission and discharge dates if additional information becomes available, a follow up report will be submitted. No other information is available that could confirm/deny the alleged event. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[146335065]
Auto-notification received from (b)(6) 23-may-2019. Subject (b)(6) is (b)(6) year-old male patient. Diagnosed with hcc on (b)(6) 2015. Presence of portal hypertension. Bilobar tumor, bclc b, index tumor of 44 mm of the right liver etiologic associations: liver cirrhosis, alcoholic cirrhosis, no prior sorafenib treatment before therasphere and no disease specific surgery. Patient was treated with therasphere: (b)(6) 2015, infused in the right artery - activity at start of infusion 3. 01 gbq; residuals remaining 0. 09gbq; lung shunt fraction 7. 4%; treatment to right lobe; 2nd treatment to left lobe on (b)(6) 2015; 2nd absorbed dose to the perfused volume 176. 4gy. Concomitant medication: octreotide (3 x per day) (b)(6) 2015, zosyn (once) (b)(6) 2015, aldactone (25 mg per day) (b)(6) 2015, lasix (40 mg per day) (b)(6) 2015. (b)(6) 2015: patient experienced: sepsis, hepatic failure; acute kidney injury; lymphocyte count decreased and blood bilirubin increase. Patient subsequently died (cause not reported) (b)(6) 2015. The events were not reported to btg by the investigator in 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00046 |
| MDR Report Key | 8648764 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-05-29 |
| Date of Report | 2019-06-28 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2019-06-28 |
| Date Added to Maude | 2019-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 FOUR FALLS CORPORATE CENTE 300 CONSHOHOCKEN STATE ROAD |
| Manufacturer City | WEST CONSHOHOCKEN, PA 194282998 |
| Manufacturer Country | US |
| Manufacturer Postal | 194282998 |
| Manufacturer Phone | 6103311537 |
| Manufacturer G1 | BIOCOMPATIBLES UK |
| Manufacturer Street | CHAPMAN HOUSE WEYDON LANE |
| Manufacturer City | FARNHAM, GU9 8QL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GU9 8QL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW |
| Product Code | NAW |
| Date Received | 2019-05-29 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES UK LTD |
| Manufacturer Address | CHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2019-05-29 |