MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-12-10 for THERASPHERE manufactured by Mds Nordion.
[1002401]
Hepatic failure leading to death. A male with esophageal cancer metastatic to the liver underwent uncomplicated therasphere radioembolization to the left lobe of the liver in 2008. At the 3 week study visit, he presented markedly jaundiced with bilateral lower leg edema, bilirubin 20 (unl <1), wbc 23,800, elevated other liver function tests gfr decreased, ct showing ascites and bile blockage. The patient was hospitalized twenty-one days later, with liver failure and underwent multiple diagnostic procedures including multiple diagnostic paracentesis which showed positive for gram positive cocci in clusters. Renal failure was also present, worsening throughout hospitalization. The patient died five days later. Cause of death was noted as acute fulminant hepatic failure and hepatorenal syndrome secondary to metastatic espophageal cancer and spontaneous bacterial peritonitis.
Patient Sequence No: 1, Text Type: D, B5
[8203483]
Note: hepatorenal failure is listed in the product package insert and is a known side effect associated with use of therasphere. However, this side effect was inadvertently excluded from the clinical trial protocol hence the assesment of this event as an unexpected adverse device effect requiring reporting to medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022247-2008-00001 |
| MDR Report Key | 1275543 |
| Report Source | 99 |
| Date Received | 2008-12-10 |
| Date of Report | 2008-12-10 |
| Date of Event | 2008-11-20 |
| Date Added to Maude | 2009-01-06 |
| 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 | 0 |
| Event Location | 0 |
| 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 | IWA |
| Date Received | 2008-12-10 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 8990085 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | OTTAWA, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2008-12-10 |