Division of Gastroenterology and Hepatology, University of Utah, Salt Lake City, UT, USA.
Department of Internal Medicine, Northwell Health, Lenox Hill Hospital, New York, NY, USA.
Esophagus. 2023 Oct;20(4):757-760. doi: 10.1007/s10388-023-01007-x. Epub 2023 Apr 21.
The BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule.
From April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
During the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158).
Findings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.
BRAVO pH 监测系统可以使持续存在 GERD 症状（尽管经过治疗和/或出现非典型症状）的患者受益。我们旨在研究与 BRAVO pH 胶囊相关的并发症的数量和类型。
从 2016 年 4 月至 2021 年 2 月，我们分析了 FDA 制造商和用户设施设备体验（MAUDE）数据库的上市后监测数据。
在研究期间，大约有 1651 份报告确定了 2391 例与设备故障相关的病例，254 例报告了与患者相关的不良事件。大多数设备并发症是由于吸入（n=153），其次是报告的疼痛（n=79）、损伤（未指定）（n=63）和额外的放射影像学检查（n=44）。裂伤和出血分别占 29 例和 19 例。此外，有 3 名患者发生穿孔。大多数设备故障是由于 Bravo 胶囊未能按照计划与食管黏膜结合或粘附（n=1269）所致，其次是激活或定位失败（n=972）、设备过早脱落（n=284）和设备无法记录或传输数据（n=158）。
MAUDE 数据库的结果强调了 BRAVO 胶囊放置的潜在并发症，包括吸入、出血/出血、穿孔、损伤和滞留的风险。
