Table 3.

Clavien-Dindo Classification grade II and III severe adverse events (SAEs) following side-to-side magnetic duodeno-ileostomy with sleeve gastrectomy through 1 year

Event	CDC Grade	Magnet related	Description
Urinary tract infection	II Mild	No	Patient presented with fever on D1, prolonging hospitalization. Urinary analysis confirmed infection; treated with 1 dose Fosfomycin; resolved with no sequelae
Dehydration	II Moderate	No	Patient hospitalized for dehydration and hypokalemia outside country 67 days (holiday); hospitalized again for nausea, vomiting, abdominal pain with suspicion of gastritis; hypokalemia was supplemented, event resolved
Post-SG ano-rexia + diarrhea, nausea, vomiting	II Moderate	No	Patient presented with diarrhea 54 days post procedure: stools watery, not bloody, ≥ 7 episodes/. 2 days later, vomiting began with dehydration, anorexia, dizziness. Abdominal CT showed no features or perforation. Hospitalized 24 h for monitoring with rehydration, IV antiemetics. Symptoms resolved without sequelae
JI obstruction on flange	III Mild	No	At procedure, mesenteric defect closed per protocol. Patient presented 115 days later with occlusion of small intestine by internal hernia in mesentery. Laparoscopic repair performed; discharged 2nd day without sequelae
Major pneumoperi-toneum on gastric fistula	III Severe	No	D2, fever (38.5 °C) developed, antibiotics started. Abdominal CT revealed major pneumoperitoneum. No objectified leakage found on exploratory laparoscopy. Patient developed sepsis; was started on amukin. Thoraco-abdominal CT (injection + barium) showed no leakage or infiltration, but with bi-basal pneumonia; treated with antibiotics. CT scan with gastrografin revealed fistula on left edge of SG + localized abscess. Stents placed and removed. Esophageal prostheses placed in lower esophagus and at EGJ. Naso-jejunal tube placed, and replaced with central line + parenteral nutrition; all later removed. Persistent para-esophageal fistula with leak. Esophageal stents removed; two stents placed in fistula. Abdominal CT with no major findings; patient discharged. SAE determined to be post-SG gastric fistula with favorable evolution after 3 months of multiple hospitalizations and treatments
Pelvic collection	III Severe	No	On D2, patient developed fever with inflammatory syndrome, tachycardia, and desaturation (7–18–22). CT showed free liquid in pelvis; antibiotics started. Patient feeling slightly better, but with persistent inflammatory syndrome; 2nd CT showed pelvic collection which was drained in surgery transvaginally under general anesthesia. Procedure complicated by bleeding 2 days after; gynecology team put stiches at vaginal incision. After 2nd fever spike, antibiotics changed. After good evolution, antibiotics stopped, and patient discharged (8–11–22) in good general condition. Patient presented to Emergency Room 10–24–22 with fever, reporting purulent vaginal bleeding that stopped 48 h before, coinciding with start of fever. She was admitted to hospital and seen by the gynecology department. CT showed pelvic collection, which was drained transvaginally. She was discharged 10–1–22 in good general condition. The source of pelvic collection was not ascertained
Cholecysto-lithiasis + choledocho-lithiasis	III Severe	No	Patient presented July 2022 with abdominal pain in upper right quadrant approx. 2 months after procedure. Investigations showed choledocholithiasis with gallstones in gallbladder. Patient underwent ERCP + sphincterotomy in July and was scheduled for cholecystectomy in October. In August, another episode of choledocholithiasis; 2nd ERCP performed in September with cholecystectomy the following day
Abdominal pain + nausea and vomiting	III Severe	No	Post procedure 4 mo., patient presented with complaints of abdominal pain on right side predominantly increasing for 2 days. Unable to eat/drink for 2 days, with this difficulty since surgery. Hospitalized for treatment; gastroscopy performed. Pain determined unrelated to study device or procedure

MS: Magnet System; DI: Duodeno-ileostomy; SG: Sleeve gastrectomy; JI: Jejunoileal; D: Day; EGJ: Esophagogastric junction; ERCP: Endoscopic retrograde cholangiopancreatography

Clavien-Dindo Classification of surgical complications [23]: Grade I: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy allowed. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition included. Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IV: Life-threatening complication (including certain central nervous system complications) requiring Intermediate Care/Intensive Care Unit-management. Grade V: Death of patient