Alerta De Seguridad para EnVeo R Delivery Catheter System

Safety alert

2016-08-04

2016-08-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160804b.html

Medical device safety alert: medtronic enveo r delivery catheter system medical device manufacturer, biomerieux, has issued a field safety notice concerning its etest colistin co256 ww. the affected product reference numbers are 537300 and 537308. medical device manufacturer, medtronic, has issued a medical device safety alert concerning its enveo r delivery catheter system (dcs) [model: enveor-l, enveor-l-c, enveor-us]. the manufacturer is issuing a letter to the health professionals regarding the potential for vascular trauma with the use of the medtronic enveo r delivery catheter system (dcs). while the reports of vascular trauma received by the manufacturer have been infrequent (0.136%; 39 events), they have included serious outcomes, including patient death (0.078%; 19 events). according to the manufacturer, it’s observed rate of 0.136% for vascular trauma is lower than the transcatheter valve therapy (tvt) registry reports in the journal of the american college of cardiology (holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. the manufacturer conducted a thorough investigation and identified recommendations, regarding patient anatomy considerations and procedural uses, to reduce the rate of vascular trauma events 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 4 august 2016.