Table 4.
Serious adverse events from the EndoBarrier device (GI Dynamics safety reporting 2008 to March 2017)
| 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 (January –March) | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Distributed devices | 25 | 143 | 157 | 275 | 391 | 812 | 987 | 482 | 383 | 43 | |
| Hepatic abscess | 0 | 0 | 0 | 0 | 1 | 8 | 12 | 9 | 4 | 2 | 36 |
| Hepatic abscess rate | 1.0% | ||||||||||
| Hepatic abscess with explant ≤12 months | 0 | 0 | 0 | 0 | 1 | 5 | 9 | 7 | 1 | 2 | 25 |
| Hepatic abscess rate | 0.7% | ||||||||||
| Intolerance | 0 | 5 | 4 | 12 | 5 | 10 | 11 | 4 | 18 | 0 | 69 |
| Intolerance rate | 1.9% | ||||||||||
| Liner obstruction | 0 | 4 | 0 | 5 | 3 | 1 | 10 | 2 | 0 | 0 | 25 |
| Liner obstruction rate | 0.7% | ||||||||||
| GI bleed | 0 | 1 | 3 | 6 | 5 | 9 | 20 | 8 | 4 | 1 | 57 |
| GI bleed rate | 1.5% | ||||||||||
| Migration/Movement | 0 | 10 | 6 | 4 | 1 | 6 | 11 | 13 | 0 | 1 | 52 |
| Migration/Movement rate | 1.4% | ||||||||||
| Pancreatitis | 0 | 0 | 0 | 0 | 4 | 1 | 7 | 0 | 0 | 0 | 12 |
| Pancreatitis rate | 0.3% | ||||||||||
| Perforation | 0 | 0 | 1 | 0 | 0 | 5 | 2 | 2 | 1 | 0 | 11 |
| Perforation rate | 0.3% | ||||||||||
| Surgical removal | 0 | 0 | 0 | 1 | 1 | 0 | 8 | 1 | 1 | 0 | 12 |
| Surgical removal rate | 0.3% | ||||||||||
| Total incidence | 0 | 20 | 14 | 28 | 20 | 40 | 81 | 39 | 28 | 4 | 274 |
| Total cumulative rate | 7.4% | ||||||||||