Medical devices, improperly manufactured and designed, that are allowed to bypass the standard pathway for testing and approval, may inadvertently cause extensive injury or death to the patient, says Alabama liability attorney Keith T. Belt . Cook Medical’s Zilver PTX drug-eluting stent for peripheral artery disease has been recalled because of a defect in its associated delivery system, the company and the FDA said. One patient death has occurred as a result of the problem, and another patient suffered an unspecified adverse event. The recall covers all lots of the product distributed from Dec. 13, 2012, through April 16 of this year. The Zilver PTX Drug-Eluting Peripheral Stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.
- Self-expanding nitinol stent is designed for the SFA.
- Randomized controlled trial demonstrates a clear drug effect: a 53% reduction in re-interventions at two years compared with bare metal stenting.1
- Paclitaxel coating involves no polymers, which eliminates the risk associated with polymers.