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Table 1 Adverse Events related to the device, anti-reflux surgery or surgery in general

From: Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

Adverse Events during surgery and in the postoperative course up to 6 months

Number of subjects

n (%)

Number of events

n

Full recovery with intact treatment effect

Number of Adverse Events (n = 50)

8 (16%)

11

YES

Device related adverse events (SADE or ADE)

0

0

 

Surgical non-device related serious adverse events (SAE)

4 (8%)

6

YES

Severe

 Mediastinal abscess, empyema and abdominal abscess

1a

3

YES

 Intra-abdominal haemorrhage

1

1

YES

Moderate

 Pleuritis

1

1

YES

Mild

 Removal of foreign body (part of a needle from the abdominal wall)

1

1

YES

 Surgical non-device related non-serious adverse events (AE)

4 (8%)

5

YES

Moderate

 Abdominal pain and incisional hernia

1b

2

YES

Mild

 Accidental intra-operative instrumental hepatic lesion (small)

1

1

YES

 Post-op delayed gastro-intestinal paralysis (one day)

1

1

YES

 Procedural pneumothorax

1

1

YES

Adverse Events between 6 months and 1 yearc

1 (2%)

1

YES

Device related adverse events (SADE or ADE)

0

0

 

Surgical non-device related serious adverse events (SAE)

1 (2%)

1

YES

Moderate

 Release of fundoplication sutures – successfully re-sutured

1

1

YES

  1. The analysis is based on 50 subjects, i.e. all subjects included in the safety analysis set
  2. a The events occurred in the same subject (caused by an infection unrelated to the device, which was unaffected in its enclosed pouch)
  3. b The events occurred in the same subject (a small hernia in the abdominal wall)
  4. c Four AEs of gastritis occurred in 4 subjects all with endoscopy verified gastritis and lack of esophagitis, all resolved