On 30 June 2017, Lombard Medical notified the UK Medicines and Health products Regulatory Agency (MHRA) about problems with the Altura stent graft device. The letter stated that all lot numbers in the catalogues 01-AA-24-090, 01-AA-27-090 and 01-AA-30-090 were being recalled.
According to the Urgent Field Safety Notice issued by the company, “on 21 June 2017 and 28 June 2017 difficulty was encountered operating the top-cap release mechanism of an Altura aortic stent graft component. As a consequence, it was difficult to release the stent graft from the delivery system. On 21 June, manoeuvres with the delivery system eventually released the stent graft and on 28 June, disassembly of the handle allowed the release mechanism to operate. On 28 June, the stent graft was displaced from its intended landing position. A renal stent was required to maintain renal patency.”
The letter also informs, “Continued use of the device may involve the risk of difficulty releasing the stent graft from the delivery system and the risk of miss-positioned stent grafts placed in the aorta. This issue is associated with the delivery system only and can only occur during implantation. There is no risk to patients already implanted with the device and the standard routine of care should be followed.
Lombard says that users should immediately segregate all affected devices from the catalogues mentioned in the letter and kept securely where they cannot be used (quarantined). A Lombard Medical representative would make arrangements to remove the affected devices.
