MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-11-20 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[185486115]
Btg medical assessment: case #1: 90y-pet/ct to visualize deposition in the lung a (b)(6)-year-old female patient with a history of alcoholic liver cirrhosis and breast cancer presented with advanced stage hepatocellular carcinoma (hcc) (barcelona clinic liver cancer c) with a tumor in segment iii of the liver and tumor thrombus in the left segmental portal branch. Post maa, planar scintigraphy showed a considerable lung shunt fraction (lsf) of approximately 50%, contraindicating radioembolization treatment. A second pre treatment angiography was performed with a scout dose of holmium-166 (166ho) microspheres was performed. During 166ho scout angiography, a more distal injection location was selected and the scout dose was injected. Spect/ct showed favorable tumor targeting and a lower lung shunt fraction, quantified as 6%. Taking this into account, the treatment was perform with a conservative activity of 1. 3 gbq of therasphere, (aiming for a 120 gy average absorbed dose in the target volume). This activity was considered safe, as even with an lsf of 50%, the maximum lung absorbed dose would not exceed 30 gy. The next day, 90y-pet/ct showed good tumor targeting, as well as visual signs of a lung shunt. The activity in the lungs as quantified on 90y-pet/ct revealed an absorbed lung dose of approximately 17 gy which was below the assumed threshold of 30 gy. Three weeks post-treatment, the patient developed symptoms of pneumonia that were unresponsive to antibiotic therapy, there were no anomalies on cect. However, at 3. 5 months post-treatment, cect of the lungs showed changes consistent with radiation-induced fibrosis. 90y-pet/ct was used to detect lung shunting and to calculate the lung absorbed dose. Even the over-estimation of the lung shunt by maa is known to over-estimate the lung shunt, the investigator used a no validated method to estimate the lung shunt (ho166 scout dose) for therasphere. The alignment to the ifu should have avoided this complication. This woman was treated for a breast cancer, the previous treatment (chemotherapy and chest radiation) should have been considered before treatment no device malfunction or failure. Lung shunting. 50% (contra-indicated): severity 3; serious; not related device - concomitant disease; anticipated. Lung fibrosis: severity 3; serious; related device; anticipated. Radiation pneumonia: severity 3; serious; related device; anticipated. No batch review was possible for this case as the batch number(s) could not be ascertained and the product was not returned for evaluation (devices remain implanted in the patients and information was obtained via a literature review). No product malfunction/deficiency has been identified or reported. No corrective/preventative action has been identified. Should we receive any information to enable further investigations, a follow-up report will be submitted. At this time this report is considered final. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185486116]
Review of literature article: the value of yttrium-90 pet/ct after hepatic radioembolization:a pictorial essay. Authors: ahmed a alsultan et al. Case #1: 90y-pet/ct to visualize deposition in the lung. A (b)(6)-year-old female patient with a history of alcoholic liver cirrhosis and breast cancer presented with advanced stage hepatocellular carcinoma (hcc) (barcelona clinic liver cancer c) with a tumor in segment iii of the liver and tumor thrombus in the left segmental portal branch. Post maa, planar scintigraphy showed a considerable lung shunt fraction (lsf) of approximately 50%, contraindicating radioembolization treatment a second pre treatment angiography was performed with a scout dose of holmium-166 (166ho) microspheres was performed. During 166ho scout angiography, a more distal injection location was selected and the scout dose was injected. Spect/ct showed favorable tumor targeting and a lower lung shunt fraction, quantified as 6%. Taking this into account, the treatment was perform with a conservative activity of 1. 3 gbq of therasphere, (aiming for a 120 gy average absorbed dose in the target volume). This activity was considered safe, as even with an lsf of 50%, the maximum lung absorbed dose would not exceed 30 gy. The next day, 90y-pet/ct showed good tumor targeting, as well as visual signs of a lung shunt. The activity in the lungs as quantified on 90y-pet/ct revealed an absorbed lung dose of approximately 17 gy which was below the assumed threshold of 30 gy. Three weeks post-treatment, the patient developed symptoms of pneumonia that were unresponsive to antibiotic therapy, there were no anomalies on cect. However, at 3. 5 months post-treatment, cect of the lungs showed changes consistent with radiation-induced fibrosis. 90y-pet/ct was used to detect lung shunting and to calculate the lung absorbed dose. Adverse events: lung shunting; lung fibrosis; radiation pneumonia are anticipated adverse events listed in the risk management documentation. No device malfunction or failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00066 |
| MDR Report Key | 9346071 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-08 |
| Date Mfgr Received | 2019-11-08 |
| Date Added to Maude | 2019-11-20 |
| 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 | 2019-11-20 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-11-20 |