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.
데이터 추가 비고
Stent, iliac - Product Code NIO
원인
Cook ireland received a product complaint from japan on december 22nd, 2011. the complainant reported that a 5 french zilver vascular stent (part number ziv5-18-125-8-80 from lot# cf694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. after further examination, the user determined that the product was a 6 french zilver vascular stent (part number ziv6-35.
조치
The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events.
If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.
Worldwide distribution: USA (nationwide) and country of: Japan.
제품 설명
Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.