iGIE : innovation, investigation and insights · 2023
Device failures and patient-related adverse events associated with endoscopic variceal ligation devices: a MAUDE database analysis.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Tatro Eric S, Adler Douglas G
Аннотация
BACKGROUND AND AIMS: Endoscopic variceal ligation (EVL) is indicated in the treatment of esophageal variceal hemorrhage. Despite the widespread use of EVL, there is a shortage of studies comparing the 2 most widely used banding devices available in the United States. We aimed to investigate outcomes associated with these devices following U.S. Food and Drug Administration approval.
METHODS: We analyzed postmarketing surveillance data for the Boston Scientific Speedband Superview Super 7 and the Cook Endoscopy 6 Shooter banding devices from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to September 2021.
RESULTS: During the study period, 3531 reports describing 4720 device failures and 258 patient-related adverse events were identified. Of the 2782 reports in the Boston Scientific device group, the most common device failures reported were failure to fire (n = 1878 [49.1%]) and premature activation (n = 486 [12.7%]); the most common patient-related adverse event was bleeding/hemorrhage (n = 62 [63.3%]). Of the 749 reports in the Cook Endoscopy device group, the most common device failures reported were premature activation (n = 218 [24.4%]) and failure to fire (n = 181 [20.2%]); the most common patient-related adverse event was presence of a foreign body (n = 111 [69.4%]).
CONCLUSIONS: Both commercially available EVL devices had significant reports of failure to fire and premature activation. Inadvertent bleeding/hemorrhage may be an underrecognized adverse event of EVL. These findings can inform operators of these devices about potential failures and their relative risk of resultant patient injury.
METHODS: We analyzed postmarketing surveillance data for the Boston Scientific Speedband Superview Super 7 and the Cook Endoscopy 6 Shooter banding devices from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to September 2021.
RESULTS: During the study period, 3531 reports describing 4720 device failures and 258 patient-related adverse events were identified. Of the 2782 reports in the Boston Scientific device group, the most common device failures reported were failure to fire (n = 1878 [49.1%]) and premature activation (n = 486 [12.7%]); the most common patient-related adverse event was bleeding/hemorrhage (n = 62 [63.3%]). Of the 749 reports in the Cook Endoscopy device group, the most common device failures reported were premature activation (n = 218 [24.4%]) and failure to fire (n = 181 [20.2%]); the most common patient-related adverse event was presence of a foreign body (n = 111 [69.4%]).
CONCLUSIONS: Both commercially available EVL devices had significant reports of failure to fire and premature activation. Inadvertent bleeding/hemorrhage may be an underrecognized adverse event of EVL. These findings can inform operators of these devices about potential failures and their relative risk of resultant patient injury.