WebMar 25, 2015 · The second assessment aimed to determine maximum ex vivo changes induced by the pusher of the ECDS (Figure 2(b)).The pusher secures the position of the valve within the system during the passage through the sheath, and the diameter of the pusher is larger than the diameter of the crimped valve (Figure 2(b)).The respective … WebThe device identification (di) numbers for edwards esheath introducer set are (b)(4). According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement ...
MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ESHEATH INTRODUCER …
Webof the introducer sheath 14. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 15. Active bacterial endocarditis within 180 days of the valve implant procedure 16. Stroke or transient ischemic attack within 90 days of the valve implant procedure 17. WebJun 23, 2014 · The Edwards eSheath Introducer Set is substantially equivalent in function, performance, and design to the RetroFlex 3 Introducer Sheath Set (K093877) and Solopath Balloon Expandable Transfemoral Introducer (K100819). The Edwards eSheath and the Solopath Introducer have an expandable shaft. 2-001 K141696, 510(k) Summary page … hbo winning time schedule
MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH …
WebThe Edwards eSheath introducer set must be used with a compatible 0.035” (0.89 mm) guidewire to prevent vessel injury. Precautions: Caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F Edwards eSheath introducer set respectively. Use caution in tortuous or ... WebAn introducer sheath can be used to safely introduce a delivery apparatus into a patient's vasculature (e.g., the femoral artery). An introducer sheath generally has an elongated sleeve that is inserted into the vasculature and a housing that contains one or more sealing valves that allow a delivery apparatus to be placed in fluid communication with the … WebThe introducer sheath model and size are unknown. The possible sheaths used: retroflex 3 introducer sheath set - pma k093877, or ascendra introducer sheath set - pma p110021, ascendra+ introducer sheath set - pma p130009, ascendra 3 introducer sheath set pma - p110021, or edwards expandable introducer sheath set - pma p130009, edwards … hbo winning time series