DYNALINK™ .035”
Peripheral Self-Expanding Stent System

1.0	DEVICE DESCRIPTION

The DYNALINK™.035" Peripheral Self-Expanding Stent System includes a self-expanding nickel titanium stent pre-mounted on an over-the-wire 0.035" (0.89 mm) delivery system. Radiopaque markers identify the stent location, as illustrated in Figure 1.

The catheter is comprised of a retractable sheath that covers the stent during delivery, a radiopaque tip, an internal guide wire lumen, and a proximal housing assembly (Figure 2), with a safety lock and a pullback handle. The entire system is shown in Figure 3. With the system in the unlocked position, retracting the pullback handle deploys the stent.

Figure 1: Tip Detail Showing Proximal Marker and Stent Locations

Retract Pullback Handle to Deploy

Flush Port

Place Thumb Here

Lock Mechanism
(Open Position)

Figure 2: Handle Detail Showing Lock, Flush Port and Finger Locations

Figure 3: Delivery System Schematic

The DYNALINK™.035 Peripheral Self-Expanding Stent is available in several lengths and diameters as listed in Table 1. Stents should always be sized to the reference vessel and should provide stent-to-artery ratios between 1.1:1 and 1.4:

Table 1 – DYNALINK™ .035" Peripheral Self-Expanding Stent System Sizes

Unconstrained Stent Diameter (mm)

Nominal Stent Length (mm)

Sheath Compatibility

Reference Vessel Diameter (mm)

2.0	INDICATIONS

The DYNALINK™.035" Peripheral Self-Expanding Stent System is indicated for the stenting of peripheral arteries as an adjunct to peripheral transluminal angioplasty.

3.0	CONTRAINDICATIONS

DYNALINK™.035" Peripheral Self-Expanding Stent System is not intended for use in patients in whom anticoagulant and/or antiplatelet therapy is contraindicated.

4.0	WARNINGS

DO NOT USE IF TEMPERATURE INDICATOR IS BLACK.

Should unusual resistance be felt at any time during lesion access or Delivery System removal, the guiding catheter or sheath and stent system should be removed as a single unit. Applying excessive force to the stent Delivery System can potentially result in loss or damage to the stent and Delivery System components. (See Stent/System Removal – Precautions. )

Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.

The stent is not designed for repositioning or recapturing.

Persons allergic to nickel titanium may suffer an allergic reaction to this implant.

Only physicians familiar with the complications, side effects and hazards commonly associated with peripheral stent placement should use this device.

Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the DYNALINK™.035" Peripheral Self-Expanding Stent System, for their intended uses, contraindications, and potential complications.

When multiple stents are required, stent materials should be of similar composition.

5.0	PRECAUTIONS

Carefully inspect the DYNALINK™.035" Peripheral Self-Expanding Stent System to verify that the device has not been damaged in shipment. Take care to avoid unnecessary handling, which may kink or damage the delivery system.

5. 1	Stent Handling - Precautions

•	For single use only. Do not re-sterilize or reuse. Note the product "Use By" date.

•	Do not remove stent from its Delivery System as removal may damage the stent and/or lead to stent embolization. Stent system is intended to perform as a system.

•	Delivery System should not be used in conjunction with other stents.

•	Special care must be taken not to handle or in any way disrupt the stent on the Delivery System. This is most important during catheter removal from packaging, mandrel removal, placement over guide wire and advancement through rotating hemostatic valve adapter and guiding catheter hub.

5. 2	Stent Placement - Precautions

•	Ensure that ALL SLACK IS REMOVED from the delivery system to enable precise stent placement.

•	Do not attempt to pull a partially expanded stent back through the sheath or guiding catheter; dislodgment of the stent from the Delivery System may occur.

•	Stent retrieval methods (use of additional wires, snares and/or forceps) may result in additional trauma to the vasculature and/or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm or embolization.

5. 3	Stent / System Removal – Precautions

Should unusual resistance be felt at any time during either lesion access or removal of the Delivery System post stent implantation, the entire system should be removed as single unit.

When removing the Delivery System as a single unit:

•	Do not retract the Delivery System into the guiding catheter or sheath.

•	Ensure that the handle is re-advanced to the locked position and the lock re-engaged.

•	Tighten the RHV (if applicable) to secure the Delivery System to the guiding catheter; then remove the guiding catheter or sheath and delivery system as a single unit.

5. 4	Post Implant - Precautions

•	Great care must be exercised when crossing a newly deployed stent with a guide wire, balloon or Delivery System to avoid disrupting the stent geometry.

•	Do not perform a magnetic resonance imaging (MRI) scan on patients post-stent implantation until the stent has completely endothelialized (eight weeks) to minimize the potential for migration. The stent may cause artifacts in MRI scans due to distortion of the magnetic field.

6.0	POTENTIAL ADVERSE EVENTS

Adverse events may be associated with the use of a stent in peripheral arteries:

•	Dissection

•	Drug reactions to antiplatelet agents/contrast medium

•	Emboli, distal (air, tissue or thrombotic emboli)

•	Hemorrhage, requiring transfusion

•	Hypotension/Hypertension

•	Infection and pain at insertion site

•	Perforation

•	Pseudoaneurysm, femoral

•	Restenosis of stented segment

•	Spasm

•	Stent embolization

•	Stent thrombosis/occlusion

7.0	HOW SUPPLIED

Sterile. Sterilized with electron beam radiation. Non-pyrogenic. Do not use if the package is open or damaged.

Contents. One (1) DYNALINK™ .035" Peripheral Self-Expanding Stent System

Storage. Store at room temperature only.
DO NOT USE IF TEMPERATURE INDICATOR IS BLACK.

8.0	CLINICIAN USE INFORMATION

8.1	Inspection Prior To Use

Inspect the temperature indicator on the inner pouch. Do not use if BLACK. Remove the Delivery System from its protective packaging. Remove the proximal packaging mandrel from the handle assembly. Then remove the handle from the package and the shaft from the hoop. Lay the device flat and minimize excessive handling. THE SHAFT MAY KINK IF NOT HANDLED CAREFULLY. Remove the cover, which protects the stent and Delivery System sheath. Inspect the stent through the clear plastic Delivery System sheath to verify that it has not been damaged during shipment, and that the stent does not overlap the proximal marker. Ensure that the stent is fully covered by the sheath. Examine the label on the housing assembly and verify that the stent is the correct diameter and length. Do not use if any defects are noted.

Do not remove the stent from the Delivery System prior to use.

8.2	Materials Required

•	Introducer sheath (or guiding catheter) suitable for contra-lateral delivery. Minimum length is 45 cm.

•	Minimum sheath or guiding catheter internal diameter is 0.084" (2.13 mm)

•	Two to three 10-20 cc syringes

•	1,000 u/500 cc of Heparinized Normal Saline (HepNS)

•	0.035" (0.89 mm) guide wire
This device is not compatible with any guide wire larger than 0.035" (0.89 mm).

•	Rotating hemostatic valve (RHV) of appropriate size, if applicable

•	DYNALINK™.035" Peripheral Self-Expanding Stent System

•	PTA balloon dilatation catheter

•	Torque device

•	Guide wire introducer

8.3	Preparation

8.3.1	Lesion Preparation

1.	Pre-dilate the lesion with an appropriate size balloon dilatation catheter.

2.	Withdraw the balloon dilatation catheter while leaving the guide wire in place.

8.3.2	Delivery System Preparation

LEAVE THE SAFETY LOCK CLOSED UNTIL THE STENT IS READY TO DEPLOY.

1.	With the distal packaging mandrel in place, inject heparinized saline into the lumen through the proximal luer fitting at the end of the housing assembly. Flush until fluid is observed exiting distally near the stent. Hold the distal tip of the Delivery System as in Figure 4. DO NOT HOLD THE STENT.

2.	Gently twist and pull to remove the mandrel. If the mandrel is not easily removed, do not use the device.

3.	Continue flushing until fluid is observed exiting at the distal portion of the tip.

4.	Keep the device lying flat to avoid kinking in the shaft.

DO NOT HOLD SHEATH

TWIST AND PULL

HOLD MANDREL HERE

HOLD TIP HERE

Figure 4: Package Mandrel Removal Demonstration

(Hold the tip to remove the packaging mandrel. )

8.4	Delivery Procedure

1.	After the pre-dilatation catheter has been removed, BACKLOAD the delivery system onto the 0.035" (0.89 mm) guide wire.

2.	Advance the Delivery System over the guide wire up to the lesion site. Use the radiopaque markers to locate the stent.

3.	If an RHV is utilized, ensure that the RHV remains OPEN and that bleed back is observed.

8.5	Stent Deployment

1.	Place the housing on a stable surface or on the patient’s leg. Ensure that the Delivery System remains flat and straight. Remove all slack. Do not loop the delivery system.

2.	Turn the safety lock counter clockwise to the deployment position, symbolized by an open padlock icon.
The arrow on the lock will point in the direction the handle will move. If an RHV is used, ENSURE THAT THE RHV IS OPEN and bleed back is observed.

3.	Position the stent using the markers. Confirm the stent position angiographically. Adjust the stent position if necessary.

4.	Ensure all slack is removed from the Delivery System before stent deployment.

5.	The device is designed to be deployed using one hand for handle retraction. Position the thumb in the textured proximal groove and place two fingers on the pullback handle as shown in Figure 5.

6.	Place the other hand on the sheath or RHV valve on the guiding catheter.
ENSURE THAT THE SHEATH or GUIDING CATHETER DOES NOT MOVE DURING DEPLOYMENT.

7.	While pressing down with the thumb to avoid any forward motion, retract the pullback handle.
Note: If significant resistance is encountered during handle retraction before the stent is deployed, re-advance and re-lock the handle and remove the device and sheath or guide.

8.	After removal from the lesion, re-advance the sheath and re-lock the Delivery System before removal into the sheath or guiding catheter. Remove the Delivery System from the patient.

9.	If desired, the stent can be post-dilated with a dilatation catheter to ensure good stent apposition.
DO NOT EXPAND THE STENT PAST ITS LABELED MAXIMUM UNCONSTRAINED DIAMETER.

Place Fingers here
Retract Pullback Handle to Deploy

Lock Mechanism Opened Position

Push down here with the thumb

Figure 5: Deployment Demonstration

(With the guide position fixed, deploy with one hand. PUSH DOWN on thumb groove and retract. )

8.6	Removal Procedure

1.	While maintaining guide wire position withdraw Delivery System.

NOTE. Should unusual resistance be felt at any time during either stricture access or removal of Delivery System post-stent implantation, the entire system should be removed as a single unit. See Stent/System Removal - Precautions section for specific Delivery System removal instructions.

2.	Repeat cholangiography to confirm optimal stent apposition.

ASSURE STENT IS NOT UNDERDILATED. DO NOT EXPAND THE STENT PAST ITS LABELED MAXIMUM UNCONSTRAINED DIAMETER. If necessary, post dilate within stent. Post dilatation balloon diameters should closely match bile duct reference diameter.

9.0	PATENTS

This product and its use are protected by one or more of the following patents. United States:

Other U. S. patents pending. Foreign patents issued and pending.