Events

Rappel de Zilver PTX DrugEluting Peripheral Stent

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cook, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64975
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1274-2013
  • Date de mise en oeuvre de l'événement
    2013-04-18
  • Date de publication de l'événement
    2013-05-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117571
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Stent, superficial femoral artery, drug-eluting - Product Code NIU
  • Cause
    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.
  • Action
    Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Device

Zilver PTX DrugEluting Peripheral Stent
  • Modèle / numéro de série
    REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
  • Description du dispositif
    Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 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 Preven 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.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Adresse du fabricant
    Cook, Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA