方法:数据库审查。
方法:三级护理神经学中心。
方法:发生不良事件的患者。
方法:MAUDE数据库评估咽鼓管球囊扩张术(ETBD)治疗咽鼓管功能障碍。
方法:分析来自MAUDE数据库的医疗器械报告(MDR)在不同ETBD器械中的不良患者事件(AE)和器械故障(DM)。该分析的目的是评估AE率并在不同设备之间进行比较。销售数据也用于计算AE率。
结果:在MAUDE数据库中,在最初的23项结果中,有18项MDRs用于接受ETBD的患者。当分离到设备中时,Aera总共有9次MDR(50%),Xpress有8个(44.4%),Audion有1个(5.6%)。有10个AE和8个DM。当通过设备分离时,Aera有4个AE和5个DM,Xpress有5个AE和3个DM,Audion有1个AE。最常见的AE是皮下气肿(n=4),头颈部有纵隔受累的报告。利用这些销售数据,Aera气球的MDR率为0.0128%,AE率为0.0058%。Audion球囊的MDR和AE率为0.0164%。
结论:ETBD是一种安全的手术,并发症少,皮下肺气肿是最常见的不良事件,与文献结果一致。全面分析AE,再加上销售数据,表明Aera气球的MDR率很低,为0.0128%,而Audion气球的MDR率为0.0164%。这些发现提供了有关术后期望和与患者进行知情同意讨论的宝贵见解。强调ETBD作为干预措施的整体安全性。
METHODS: Review of database.
METHODS: Tertiary care neurotology center.
METHODS: Patients undergoing adverse events.
METHODS: MAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction.
METHODS: Medical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates.
RESULTS: There were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %.
CONCLUSIONS: ETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.