Inferior vena cava filters 의 안전성 경고

Safety alert

2016-07-26

2016-07-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160726.html

Medical device safety alert: inferior vena cava filters the health canada has issued a medical device alert concerning inferior vena cava (ivc) filters. the manufacturers, models and categories of the affected devices are as follows: manufacturermodelcategory ‧a.L.Naln vena cava filterretrievable ‧bard peripheral vasculardenali vena cava filterg2 filter systemsimon nitinol vena cava filterretrievableretrievablepermanent ‧b. braun medicalvenatech lp vena cava filter systempermanent ‧cordis casheloptease vena cava filtertrapease permanent vena cava filterretrievablepermanent ‧rex medical, lpoption retrievable vena cava filter systemretrievable ‧william cook, europe aps and cook, inc.Cook celect platinum vena cava filtercook celect vena cava filtergianturco-roehm birds nest vena cava filtergunther tulip vena cava mreye filter setretrievableretrievablepermanentretrievable as of june 6, 2016, health canada has received 121 incident reports of serious complications associated with ivc filters. these complications have also been reported internationally. serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with ivc filters. many of these complications occurred with long-term (greater than 30 days) filter implantation. health canada has recently completed a review of the clinical evidence for the safety and effectiveness of ivc filters. although there have been numerous clinical studies of ivc filters, there are only two randomized controlled trials (rcts) of ivc filter use. in both studies, patients with documented venous thrombo-embolism (vte) were randomized to therapeutic anticoagulation alone or to therapeutic anticoagulation plus an ivc filter. results from these two rcts do not support the use of ivc filters in patients who can be treated with anticoagulation. reductions in vte and mortality have not been demonstrated. health canada is communicating to healthcare professionals that ivc filters are appropriate for patients with certain types of blood clots, who cannot be treated with anticoagulant drugs. health canada is also working with the manufacturers of ivc filters to continue to monitor the post-market safety and effectiveness of ivc filters in canada as well as worldwide. for details, please visit the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59518a-eng.Php posted on 26 july 2016.