Lariat Suture Delivery Device 의 안전성 경고

Safety alert

2015-07-14

2015-07-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150714.html

Medical device safety alert: sentreheart lariat suture delivery device the united states food and drug administration (fda) has issued medical device safety alerts concerning lariat suture delivery device, manufactured by sentreheart. the fda is alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the lariat suture delivery device and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke. the fda identified 45 adverse events through june 30, 2015 that occurred in patients undergoing left atrial appendage (laa) closure procedures with the lariat suture delivery device and/or its associated devices. these reports describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete laa detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). of the 45 adverse events reported to the fda, 34 (approximately 75%) resulted in the need to perform emergency heart surgery. to reduce the risk of stroke in patients with atrial fibrillation, the fda advises healthcare professionals to consider treatment options for which safety and effectiveness have been established. prior to treatment, health professionals should inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke. for details, please refer to the fda websites: http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm454501.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm454660.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 july 2015.