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Jun 26 2013

Zilver Stent Recalled After A Patient’s Death, System May Break

Posted in Community Service, Nursing Home, Product Liability
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 .

Zilver PTX

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.
The firm said it had received 13 reports that the delivery system had separated at the tip of the inner catheter. Such events could result in surgery to retrieve the catheter tip, vascular blockage from unretrieved tips, thrombosis, amputation, or cardiac arrest, Cook Medical said. The FDA has designated the recall as Class I because of the serious risks. On the basis of the number of stent systems distributed, Cook Medical estimated that problem had occurred in 0.043% of placements. The firm said the bare metal version of the stent uses a different delivery system and is not included in the recall. It also emphasized that, when paclitaxel-eluting stents were implanted and the delivery devices removed intact, patients are at no risk. Customers who bought the paclitaxel-eluting peripheral stent during the period covered by the recall should quarantine remaining inventory and return it to the company for credit.