Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.
Publicado el 22 de mayo de 2013 · Inicio del retiro: 18 de abril de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cook, Inc.
- Distribuidor
- Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
- Lote
- REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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