Agile (biliarny stent)

2019: A withdrawal of the rejected stents

On January 30, 2019 Boston Scientific began a voluntary selective withdrawal of the rejected X-ray contrast stents for bilious channels of Agile. According to the published report on security, these devices were displaced after installation, despite the silicone covering designed to reduce risk of growing into fabrics and shifts of the stent from nickel-titanium alloy.

The company announced that it received messages about higher, than it was expected, speeds of shift of Agile stents. This undesirable phenomenon can demand additional interventions and repeated stenting as the displaced stent does not allow to get rid of a striktura of bilious channels.

Boston Scientific recalls the rejected stents which are displaced after implantation

Boston Scientific stated that it does not recommend to delete already implanted devices which adequately perform the function. However representatives of the company advised doctors to watch carefully such patients and if necessary immediately to help them according to standards.

The voluntary response concerns Agile stents with model numbers M00586000, M00586010, M00586020, M00586060, M00586070 and M00586080 and also GTIN numbers 08714729950219, 08714729950226, 08714729950264, 08714729950271 and 08714729950288.

The company offered doctors and to hospitals which own Agile stents with these numbers, immediately to stop their use and to return all rejected devices to the producer. If immediate return is impossible, it is recommended to assemble all devices, to seal up and store until delivery in the place, unavailable to health workers. The company calls health workers as it is possible to distribute more widely this information in the professional sphere whenever possible quickly to recall all rejected Agile devices from the market.^[1]

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