【文章內(nèi)容簡(jiǎn)介】 rotection System Filter Deployment incorrect CORRECT Photograph taken by Boston Scientific Corporation Confidential For Internal Use Only Do Not Copy or Distribute. 26 of 128 4. Once the delivery sheath is pletely removed, inject contrast and verify the device is in the proper position and there is adequate flow. NOTE: If repositioning is required, the EZ Retrieval Sheath should be used. Retract the protection wire and filter loop into the sheath, reposition the filter and redeploy. 5. Use the protection wire like a traditional guide wire to track catheters and stent delivery systems to the target treatment area. FilterWire EZ? Embolic Protection System Filter Deployment (continued) Confidential For Internal Use Only Do Not Copy or Distribute. 27 of 128 contrast frequently and always after any intervention or exchange, to visually verify that blood flow is not obstructed and that filter loop/vessel apposition to the vessel wall is maintained. CAUTION: If a filter bees occluded during the procedure, remove it and deploy a second filter if further intervention is required. the procedure making sure the protection wire remains in the proper position distal to the lesion (monitor fluoroscopy). Note: Failure to stabilize the protection wire could lead to inadvertent movement of the filter, resulting in protection wire entanglement and/or delay in the procedure. FilterWire EZ? Embolic Protection System During the Procedure Confidential For Internal Use Only Do Not Copy or Distribute. 28 of 128 FilterWire EZ? Embolic Protection System Filter Capture and Retrieval the EZ Retrieval Sheath from its packaging coil and flush with heparinized saline. the retrieval sheath over the protection wire past any deployed stents up to the proximal end of the filter loop. Note: If the EZ Retrieval Sheath is not able to pass the deployed stent, be sure the stent is well apposed and consider postdilitation. If the Retrieval Sheath is still unable to cross, try the EZ Bent Tip Retrieval Sheath (available separately). EZ Bent Tip Retrieval Sheath Packaging Confidential For Internal Use Only Do Not Copy or Distribute. 29 of 128 FilterWire EZ? Embolic Protection System Filter Capture and Retrieval (continued) and slowly retract the protection wire and filter loop back into the retrieval sheath until resistance is felt. the retrieval procedure under fluoroscopic imaging. Note: The distal edge of the collapsed filter loop should align with (see figure B), or be proximal to (figure A), the retrieval sheath marker band. Retrieval Sheath Marker Band A B Confidential For Internal Use Only Do Not Copy or Distribute. 30 of 128 FilterWire EZ? Embolic Protection System Filter Capture and Retrieval (continued) NOTE: If resistance is felt before the distal edge of the collapsed filter loop is aligned with the marker band, it is possible that there is a large amount of embolic debris in the filter. Carefully retract the protection wire and EZ Retrieval Sheath as a system. The distal part of the filter bag will be outside of the sheath during retrieval in this case。 however, the filter loop must be pulled fully into the sheath. Fully Retracted Filter Large Debris Load in Filter Confidential For Internal Use Only Do Not Copy or Distribute. 31 of 128 FilterWire EZ? Embolic Protection System Filter Capture and Retrieval (continued) any resistance is met during retraction of the sheathed FilterWire EZ System, slightly advance the sheathed FilterWire EZ System and rotate the sheath before continuing to retract. and carefully retract the entire system until the tip of the retrieval sheath is adjacent to the tip of the guiding catheter or guiding sheath. 7. If there is any resistance, retract the guiding catheter and FilterWire EZ System together. This is done in case there is a large amount of embolic material captured in the filter that may not fit inside the guiding catheter. Confidential For Internal Use Only Do Not Copy or Distribute. 32 of 128 FilterWire EZ? Embolic Protection System Filter Capture and Retrieval (continued) 8. Remove the FilterWire EZ System from the patient. NOTE: When using a rotating hemostasis valve, ensure that the hemostasis valve is fully opened prior to FilterWire EZ System removal. CAUTION: If a guide sheath with a fixed hemostasis valve is used, the valve dilator tool is required for FilterWire EZ System removal. Removing the FilterWire EZ System through a fixed hemostasis valve without the use of a valve dilator may cause the filter membrane to tear. 9. If a fixed hemostasis valve is used, place the valve dilator (if provided in the accessory kit) on the shaft of the retrieval sheath and slide the tool into the valve. Then remove the FilterWire EZ System from the patient through the valve dilator tool and remove the dilator. Confidential For Internal Use Only Do Not Copy or Distribute. 33 of 128 Stent Entanglement Potential for a distal embolic protection filter to entangle with a stent is inherent to interventional procedures using these devices. SAFE PRACTICE FOR DISTAL PROTECTION FILTERS: good guide catheter or guide sheath support sufficient landing zone the filter in place during deployment wire movement during the procedure full stent apposition Confidential For Internal Use Only Do Not Copy or Distribute. 34 of 128 FilterWire EZ? Embolic Protection System Tips for Use Key Success Factors for Using the FilterWire EZ System 1. Keep ACT levels ?275 seconds for carotid procedures and ?300 seconds for SVG procedures. 2. If there is difficulty crossing the lesion, try a buddy wire and/or, for carotid procedures, have the patient turn their head to the left