VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Worldwide distribution. US Nationwide, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BRUNEI, BULGARIA, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DEUTSCHLAND, EGYPT, FINLAND, FRANCE, GEORGIA, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, OMAN, PANAMA, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDIA ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES (UAE), UNITED KINGDOM, VIETNAM
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1898-2021