MAUDE Adverse Event Report: SPATZ FGIA INC; CORPOREA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Post Operative Wound Infection (2446); Stomach Ulceration (4488)

Event Type  Injury  

Event Description

Patient 1: a 36-year-old woman with a body mass index (bmi) of 34kg/m2 (class i obesity) who had undergone placement of an igb (spatz3; spatz fgia, inc., great neck, new york, united states) 5 months prior presented to the emergency room with moderate epigastric pain.She had not previously undergone gastric manipulation.She had stopped taking the prescribed proton pump inhibitor, of her own volition, 3 months prior to seeking treatment.An x-ray of the abdomen revealed no abnormalities.After analgesia, she presented improvement and was discharged.The woman returned to the emergency room 6 hours later because her pain had worsened.Physical examination revealed intense upper abdominal pain without peritoneal irritation.She was not febrile, and her heart rate was within normal limits.Computed tomography (ct) of the abdomen showed pneumoperitoneum in the sub diaphragmatic and sub hepatic regions, without free fluid in the abdominal cavity.Laboratory tests showed a white blood cell (wbc) count of 12,000/? l, without elevated proportions of band or segmented neutrophils, and a c-reactive protein (crp) level of 2mg/dl.Antibiotic therapy, water/electrolyte replacement, and analgesia were started.During upper gastrointestinal endoscopy, which was performed in the operating room, without co2 insufflation, the igb was removed.A deep ulcer, with a diameter of approximately 1cm, was identified in the anterior wall of the gastric body.The orifice was closed with two hemoclips (resolution; boston scientific, natick, massachusetts, united states), and the final appearance was satisfactory.There was no need for intensive care unit (icu) admission.On post-procedure day 3, ct showed a slight increase in the pneumoperitoneum, without leakage of fluid into the cavity.At that time, the wbc count was 14,000/? l, still without elevated proportions of band or segmented neutrophils, and the crp level was down to 1.2mg/dl.The patient was still afebrile and showed no abdominal pain on palpation.She was started on a liquid diet, which was well accepted.On post-procedure day 5, the patient was discharged with a prescription for an oral antibiotic, the liquid diet being maintained.Patient 2: a 31-year-old woman with a bmi of 31kg/m2 (class i obesity) who had undergone placement of an igb (corporea; medicone, cachoeirinha, brazil) 6 days prior and was taking a proton pump inhibitor presented to the emergency room with a 6-hour history of mild but progressively increasing pain in her left shoulder.She had no history of gastric surgery.The patient was in good general condition and afebrile, with a heart rate of 86 bpm and a blood pressure of 120/75mmhg.Physical examination revealed a flaccid, painless abdomen without signs of peritoneal irritation.An abdominal x-ray revealed no indication of pneumoperitoneum and showed the igb within the gastric pouch.Her pain worsened, migrating to the left subcostal region.After 12 hours of observation, the pain persisted, despite treatment with opioids, and a non-contrast-enhanced ct scan revealed a discrete left sub diaphragmatic liquid layer containing a small amount of air, which was also present in the perihepatic region.The igb was seen to be compressed against the anterior wall of the gastric body.Therefore, the patient was admitted.At admission, her leukocyte count was 12,900 cells/mm3, with no left shift, and her crp level was 3mg/dl.We opted for introduction of broad-spectrum antibiotic therapy, to be followed by endoscopic management.During the endoscopy, which was performed with minimal insufflation of the gastric pouch, the igb was removed.Lnsufflation with co2 was not used.Two shallow fibrin-coated ulcers (3mm and 7mm in diameter, respectively), together with a perforating lesion (approximately 3mm in diameter), were observed in the greater curvature of the stomach, extending toward the anterior gastric wall.The lesion was closed with two hemoclips (instinct; cook medical, winston-salem, north carolina, united states), and two more instinct hemoclips were applied to the ulcers to prevent bleeding.Post-procedure admission to the icu was not necessary.On post-procedure day 1, the patient's leukocyte count was 15,900 cells/mm3, with 2% rods, her crp level was 3mg/dl, and there was significant improvement in her abdominal pain.At 48 hours after the procedure, oral contrast-enhanced ct showed a reduction in the pneumoperitoneum that was restricted to the left hypochondrium and epigastrium.There was no extravasation of the oral contrast agent.At 72 hours after the procedure, the patient was free of complaints.She was started on a liquid diet, which was well accepted.Her leukocyte count was 14,900 cells/mm3, with no shift, and her crp level was 18mg/dl.The patient was discharged on day 5 after admission.At this writing, she is in outpatient treatment and is still asymptomatic.Ccn0004385 this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): SPATZ FGIA INC; CORPOREA
• MDR Report Key: 17529428
• MDR Text Key: 321139511
• Report Number: MW5136354
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 36 YR