Table 4.
Serious adverse events graded as surgical complications according to the Clavien-Dindo Scale through 18 months in the vBloc group.
| Serious adverse event | vBloc | Grade | Rationale for grade | |
|---|---|---|---|---|
| Number (%) of patients | Number of events | |||
| SAEs related to device, implant/revision, or therapy | ||||
| Neuroregulator malfunction | 2 (1.2) | 2 | IIIb (2 events) |
No abdominal surgery required, replacement with skin incision in same pocket |
| Atelectasis | 1 (0.6) | 1 | I | Analgesics and antiemetics required with observation |
| Gallbladder disease | 1 (0.6) | 1 | IIIb | Surgery for gallbladder removal required |
| Emesis/vomiting | 1 (0.6) | 1 | IIIb | Surgery to reduce and repair hiatal hernia |
| Pain, neuroregulator site | 1 (0.6) | 1 | IIIb | Skin incision, removal of fibrotic tissue, and pocket expansion required |
| Gastric perforation | 1 (0.6) | 1 | IVa | Life-threatening complication with ICU management |
|
| ||||
| SAEs related to intra-abdominal surgery | ||||
| Nausea | 6 (3.7) | 6 | I (6 events) |
Antiemetics and observation required |
| Cirrhosis∗ | 1 (0.6) | 1 | II | Transfusion required due to bleeding from liver biopsy |
| Generalized ileus | 1 (0.6) | 1 | I | Analgesics required |
| Intraoperative oozing | 1 (0.6) | 1 | I | Observation only |
|
| ||||
| Total grades | Grade I: 9 events (5.6% of patients) | |||
| Grade II: 1 event (0.6% of patients) | ||||
| Grade III: 5 events (3.1% of patients) | ||||
| Grade IV: 1 event (0.6% of patients) | ||||
∗Cirrhosis was found during the implant procedure and the patient was not implanted with a Maestro System.