Noticias

Noticias

  • Título: Vascutek initiates voluntary recall of AnacondaTM Bifurcate Body Stent Graft System
  • Fecha: 21-10-2013

  • Vascutek has today (Monday 21 October) issued a Field Safety Notice initiating a voluntary recall of the AnacondaTM Bifurcate Body Stent Graft System.

    An issue with a component of the device, the release wire in the delivery system, identified through Vascutek’s quality management monitoring system, is currently being investigated.

    The AnacondaTM system is used to treat abdominal aortic aneurysms. The AnacondaTM stent graft is effectively a new lining for the damaged section of the aorta which prevents potentially fatal rupture of the aneurysm. More than 17,000 AnacondaTM stent grafts have been implanted since the system was launched in 2005.

    Paul Holbrook, Vascutek President and CEO, said: “Vascutek has recently received three separate reports of failures in a release wire in the AnacondaTM delivery system.

    “We are fully committed to the highest standards of patient safety and product quality, and have taken the decision, as a precautionary measure, to voluntarily recall all AnacondaTM Bifurcate Body Stent Graft systems.'

    “I am confident that Vascutek engineers will find the root cause of this issue and that the AnacondaTM system will be available as quickly as possible.'

    “Patients who have previously benefitted from an AnacondaTM stent graft are not affected by this voluntary recall and should not be concerned as this failure mode is specifically associated with the delivery system used to implant the stent graft.”

    Vascutek is a world leader in the design and manufacture of products which address the needs of vascular and cardiovascular clinicians and their patients.

    For more than 30 years the company, based in Inchinnan, Renfrewshire, Scotland (UK) has applied advanced and innovative technologies to develop a wide portfolio of products which includes a AAA stent graft system and an extensive range of sealed woven and knitted polyester grafts for peripheral, abdominal and cardiothoracic surgery.

    The Vascutek range of products also features ePTFE grafts, heart valves and valved conduits.

    Paul Holbrook continued: “I would like to reassure customers that it is our intention to make the AnacondaTM system available to clinicians and their patients as quickly as possible.'

    “We will not do this until we are satisfied that the component issue which has been identified has been resolved. We will then work with relevant regulatory authorities so that patients who need this specialised and effective device have access to it as quickly as is practical.”



  • Fuente: endovascular.es