This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Death was reported in 1 patient, 1 month after the procedure, from coccidioidomycosis with multiple other chest and abdominal abscesses in a case series of 5 patients. In a case series of 6 patients, death was reported in 1 patient, 9 months after the procedure, as a result of postoperative complications after additional surgical repairs when the fistula reopened (no further details provided).
5.2 Device migration was reported in 2 patients from the case series of 6 patients. One patient presented with a recurrent pelvic abscess 7 weeks after the procedure. A colonic fistula and a small pericolic abscess, which contained the silicone footplate of the device, were identified. The colonic fistula was the recurrence of a separate defect previously closed with fibrin glue. The footplate was removed percutaneously and the abscess and fistula closed after 6 weeks of catheter drainage. In the other patient, a CT scan at 4 months showed that the silicone footplate had migrated out of the bowel lumen, causing a pre‑sacral fluid collection. The footplate was removed percutaneously and a catheter left in for drainage. The fistula recurred 9 months after the enterocutaneous fistula plug placement and the patient died from the postoperative complications following the additional surgical repairs (death reported in section 4).
5.3 One patient was admitted to hospital 2 days after the procedure because of pyrexia in a case series of 2 patients. No cause was found and no further details were given. This patient had a further admission for small bowel obstruction that resolved within 2 days of nasogastric suction (timing not reported).
5.4 The specialist advisers reported an anecdotal adverse event of severe pain during the procedure requiring conversion to general anaesthetic. They stated that theoretical adverse events could include allergic reaction, increase in diameter or output of the fistula, peritonitis and bowel contents leaking into the abdominal cavity, bowel injury, vascular injury and bleeding.