During the study period, 728 cases (Orbera = 354, Spatz3 = 374) with 1099 device issues and 1021 patient complications were reported to MAUDE.

Orbera IGBs, FDA approved in 2005, had 651 device issues between December 2020 to September 2023 with reports increasing each year since 2021 (Fig. 1a–c). Spatz3 IGBs had 448 device issues reported between November 2021 to September 2023. A similar number of device issues were reported during the first year after FDA approval in October 2021 (N = 231) and the subsequent 11 months (N = 217).

Temporal trends. Patient complications reported by year for Orbera (a) and Spatz3 (b). Device issue reports by month (c) with trendlines (Orbera = blue, Spatz3 = orange

Balloon deflation accounted for 49% and 63% of all Orbera and Spatz3 device issues, respectively. Leak (N = 140, 22%) and balloon inflation problems (N = 64, 10%) for Orbera IGBs and patient-device incompatibility (N = 45, 10%) and device migration or expulsion (N = 41, 9%) for Spatz3 IGBs, were the next most reported device issues (Table 1a). Report narratives described balloon hyperinflation (N = 29, 64%), gastric ulcer formation (N = 6, 13%), and symptomatic intolerance (N = 5, 11%) as leading reasons for patient-device incompatibility. Among this group, 10 patients required hospitalization and 22 required device removal or replacement. Hyperinflation accounted for 50% of 24 patient-device incompatibility issues, with 6 noting device removal or replacement was required.

A total of 599 patient complications involving Orbera and 422 involving Spatz3 IGBs were reported (Table 1b). Failure of implant (N = 256, 43%), vomiting (N = 83, 14%), pain (N = 77, 13%), nausea (N = 32, 5%), obstruction (N = 21, 4%), and perforation (N = 20, 3%) were leading Orbera-related patient complications. Report narratives detail IGB leak or deflation (N = 142, 55%), hyperinflation (N = 48, 19%), and migration or expulsion (N = 30, 12%) as primary causes of Orbera implant failure (Table 1c). For Spatz3, appropriate clinical signs, symptoms, conditions term or code not available (N = 265, 63%) was the most frequently indicated patient complication, followed by pain (N = 86, 20%), vomiting (N = 22, 5%), and nausea (N = 17, 4%). IGB leak or deflation (N = 215, 81%) is the leading device issue underlying “Appropriate Clinical Signs/Code Not Available” according to narrative reports. Ulcer formation and pancreatitis each accounted for ≤ 1% of all patient complications for either IGB. Six deaths were reported during the study period (Orbera = 5, Spatz3 = 1). Five were related to perforation (Orbera = 4, Spatz3 = 1), with few additional details provided, and one did not disclose a cause.