Precise Pro RX Nitinol Stent System (Carotid) 의 안전성 경고

Safety alert

2016-05-10

2016-05-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160510b.html

Medical device safety alert: cordis precise pro rx nitinol stent system (carotid) medical device manufacturer, cordis corporation, inc. (cordis) has issued a medical device safety alert concerning its precise pro rx nitinol stent system (carotid) [catalog numbers: pc0640xce, pc0730xce, pc0740xce, pc0840xce, pc0930xce and lot numbers: 17344454, 17337067, 17256212, 17308315, 17381651, 17323769, 17314384]. based on recent complaints and subsequent investigation, the manufacturer has determined that products made between 27 apr 2015 and 22 nov 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after 22 nov 2015, including product currently manufactured and supplied are not affected. there have been no patient injuries reported to the manufacturer related to this issue. according to the manufacturer, the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared; vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment; or in most severe cases, transient ischaemic attack or stroke. the manufacturer is voluntarily recalling the affected lots. according to the local supplier, the affected lots are distributed in hong kong. if you are in possession of the affected lots, please contact your supplier for necessary actions. posted on 10 may 2016.