Supplementary Table.
Periprocedural (30-day) serious adverse eventsa
| Serious adverse event | Device relatedb | Procedure relatedb | Time after procedure,c days | Statusd |
|---|---|---|---|---|
| Hyperglycemia | No | Yes | 0 | Resolved without sequelae |
| Arrhythmia | No | Yes | 1 | Resolved without sequelae |
| Postimplantation syndrome | Yes | No | 1 | Resolved without sequelae |
| Fever | Yes | No | 1 | Resolved without sequelae |
| Constipation | No | Yes | 2 | Resolved without sequelae |
| Low hemoglobin | No | Yes | 2 | Resolved with sequelae |
| Postimplantation syndrome | Yes | No | 3 | Resolved without sequelae |
| Abdominal pain | No | Yes | 5 | Resolved without sequelae |
a
Serious according to ISO 14155:2020 Clinical investigation of medical devices for human subjects – good clinical practice.
b
Probably or more likely related to the study device or study procedure, which was adjudicated by a medical monitor independently of the study investigators.
c
Day 0 is the day of procedure.
d
Status at last follow-up.