Endurant/ Endurant II 23mm and 25mm Bifurcated Stent Graft Systems 의 안전성 경고

Safety alert

2017-03-06

2017-03-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170306b.html

Medical device safety alert: medtronic endurant/ endurant ii 23mm and 25mm bifurcated stent graft systems medical device manufacturer, medtronic, has issued a medical device safety alert concerning its endurant/ endurant ii 23mm and 25mm bifurcated stent graft systems (serial numbers : enbf2313c120ee, enbf2313c145ee, enbf2313c170ee, enbf2316c120ee, enbf2316c145ee, enbf2316c170ee, enbf2513c145ee, enbf2513c170ee, enbf2516c145ee, enbf2516c170ee, etbf2313c124ee, etbf2313c145ee, etbf2313c166ee, etbf2316c124ee, etbf2316c145ee, etbf2316c166ee, etbf2513c124ee, etbf2513c145ee, etbf2513c166ee, etbf2516c124ee, etbf2516c145ee, ftef2516c166ee) according to the manufacturer, this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure. at the time of implant procedure this permeability variation may cause the physician to categorize a type iv endoleak (which typically self- resolves over time) as an acute type iii fabric endoleak because the leak may appear to be focal or a localized leak as opposed to a diffused leak (blush). the misclassification as an acute type iii fabric endoleak may lead to unnecessary secondary interventions. the permeability variation is limited to a subset of 23mm and 25mm devices that were manufactured with specific lots of graft material. this recall does not affect any other models or serial numbers of the endurant/endurant ii bifurcated stent graft systems, or other medtronic product or implantable devices. although the incremental risk associated with the affected subset of endurant/endurant ii bifurcated stent graft systems is low, there remains a potential for unnecessary secondary interventions being performed to treat a perceived acute type iii endoleak which could actually be a type iv that self-resolves over time. the manufacturer is initiating this recall to further mitigate this risk through removal of the unused affected subset of devices. through 27 january 2017, the manufacturer has received 20 complaints related to this reported acute type iii fabric leak resulting in additional interventions at the time of the procedure. there have been two reports of adverse events. one patient death was reported to have occurred three weeks post-procedure, but it is inconclusive if the death was related to the secondary procedure. the manufacturer advised that no actions are required for patients already implanted, as the potential for endoleak misclassification due to permeability variation occurs acutely at implant. patients who have been implanted with an endurant/ endurant ii 23mm or 25mm bifurcated stent graft system affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with their standard practice. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 march 2017.