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Perclose™ ProStyle™

Suture-Mediated Closure and Repair System

Perclose ProStyle
Deployment


Refer to Instructions for Use (IFU) for additional information

Deployment & Suture Management

Device Preparation

Marker Port

To prep the device, verify Marker Lumen patency by flushing it with saline until saline exits the Marker Port.

4 Key Steps to Suture Deployment

Step 1

1. Advance device & lift Lever (Open Foot)

Step 2

2. Maintain retraction and depress Plunger (Deploy Needles)

Step 3

3. Pull back Plunger (Deploy Suture)

Step 4

4. Lower Lever (Close Foot)

Suture Management

Step A

A. Load the blue (rail) suture limb in the Snared Knot Pusher (or in the Suture Trimmer) and advance the Suture Knot

Step B

B. Lock Suture Knot by pulling white (non-rail) suture limb

Step C

C. Trim suture limbs by pulling Trimming Lever

Single and Multiple Device Deployment

View the animation library for System Overview, Device Preparation, and full deployment steps for Single Device Deployment and Multiple Device Deployment techniques.

 

System Overview

Single Device Deployment

Multiple Device Deployment

Tips and Techniques

Refer to Instructions for Use for additional information.

 

Foot Break

Causes/Observations

Potential causes during Plunger deployment (Step 2)
  • Rotating/rocking the device or excessive force during Plunger deployment
  • Shallow (less than 45º) Plunger deployment angle
Foot Break
Foot Break
Potential observations after Plunger removal (Step 3) and/or device removal
  • No Suture or link present
  • Just a link and no Suture present
  • Missing part of Foot when the device is removed
Deployment Angle During plunger deployment (Step 2)
 
Incorrect angle

Shallow Deployment Angle

  • Sub-optimal in any tissue conditions
  • Potential gap between Posterior Foot and vessel wall increases chance for foot break and cuff miss
Correct angle

  45º Deployment Angle

  • Ideal in healthy compliant tissue conditions
  • Posterior and Anterior Foot appose evenly to compliant vessel wall

 

Foot Break Prevention

Footbreak Prevention steps
Footbreak Prevention steps
  1. Position the Perclose™ device at 45º angle and keep stable with the left hand during Plunger deployment
    • The deployment angle may vary slightly depending on anatomy
  2. Maintain even and gentle tension over the Anterior and Posterior Foot against the vessel wall
    • The key is to raise the device until pressure is evenly distributed across the Anterior and Posterior Foot
  3. Press down on the Plunger with a gentle, increasing pressure to advance the Needles
    • The Needles are more susceptible to deflecting off calcification with higher Plunger force and higher Needle speed
Device Removal
Device Removal steps
Device Removal steps

Before attempting to remove the device:

  • Relax the device before pushing the Lever down
  • Push the Lever down to return Foot to the closed position

Device Entrapment

Observations

Difficult or unable to lower the Lever (close the Foot) and remove device after the Suture Deployment

 

Causes & Prevention

Potential CausesPrevention
  1. Separation of Proximal Guide & Distal Guide due to excessive pressure buildup during device advancement
  • If excessive resistance is felt during device advancement, gently roll device medially and laterally to ease device entry
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation prior to Step 1 (before Open Foot)
  • Only rotate device up to 30°  from the 12 o’clock position, especially in diseased non-compliant tissue conditions
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation after Step 1 (with Open Foot)
  • Complete device rotation, if necessary, before performing Step 1 (Open Foot)
  1. Malfunction of Lever-Foot wire control mechanism due to excessive retraction force during suture deployment
  • Maintain gentle retraction against the vessel wall when depressing Plunger to deploy needles (Step 2).
  • Relax device when lowering Lever (Step 4) to close the Foot
  • Advance device slightly to restore marker flow, if necessary, before lowering the Lever
  1. Unable to close Foot due to tissue interference between Distal Guide and Posterior Foot
  • Stop device advancement once “mark” is observed from the Marker Lumen to ensure the Foot is open (Step 1) near or at the access site to minimise intraluminal travel during pull back for Step 2

Cuff Miss

Cuff Miss
No suture or link present
Cuff Miss
Cuff and link present, no Suture
  • Plunger is withdrawn and no Suture is present. The link may or may not be attached to Anterior Needle
  • Tip(s) of Needle(s) did not lock with Cuff(s)

Potential Causes

Cuff Miss
Cuff Miss
  • Tissue too thick and the Needle(s) cannot lock with Cuff(s); certain anatomical conditions such as heavily calcified arteries or scarred tissue
  • Incomplete advancement of Plunger; black Collar on Plunger did not contact Body of Perclose™ device.
  • Changing the angle, rotating or rocking the device may make the Needles more susceptible to deflection
  • Not stabilising device or maintaining the device at 45º throughout deployment and retraction of Plunger/Suture

Prevention/Resolution

Cuff Miss Prevention
Cuff Miss Resolution
Cuff Miss Resolution
Prevention
  • Proper patient selection
  • Deploy device at 45º angle
  • Maintain gentle retraction against the vessel wall
  • Stabilise device with left hand during Plunger deployment
  • Ensure black Collar on Plunger contacts the device Body
  • Maintain and stabilise the device at 45º angle throughout removal of Plunger/Needles and until Suture is fully retracted
Resolution
  • Insert wire and exchange for another device

Suture Break

Causes/Prevention

Suture Break
  • Suture may look thin and elongated
  • Rail or non-rail limbs can break
Suture Break Prevention
  • Load Suture at mid-point of Suture Trimmer (Do not load at tip)
  • Keep Thumb Knob retracted until Suture limbs drop into Suture Gate (Do not close Suture Gate on the Suture)
Suture Break Prevention
  • Keep Thumb Knob toward ceiling (Do not rotate Suture Trimmer)
  • Keep suture limbs coaxial to Suture Trimmer and tissue tract at all times
  • Do not pull laterally or medially on Suture
  • Apply slow, consistent, increasing tension (Avoid quick, jerky movements)

Poor Flow

Poor Arterial Flow / No Flow

Poor Flow Arterial
Poor Flow Arterial
Poor Flow Arterial

Resolution

Marker Port against vessel wall
  • Do not deploy Perclose™ devices with vessel diameters <5 mm
     
Side wall stick
  • Gently rotate device to move Marker Port off vessel wall
     
Low blood pressure
  • Slow drip is acceptable if Perclose™ device position is confirmed
     
Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
     
Device not in vessel lumen
  • Drip can occur when Marker Port is near vessel lumen but not completely in the vessel, especially with high blood pressure or 7/8F sheaths
  • Continue advancing the Perclose™ device until brisk pulsatile flow is observed

Poor Venous Flow / No Flow

Poor Flow Arterial
Poor Flow Arterial
Poor Flow Arterial

Resolution

No flow is possible and acceptable if device location is confirmed
  • Apply pressure on groin or lower abdomen
  • Inject contrast through Marker Lumen
  • Use ultrasound to confirm location of device
  • Have the patient perform the Valsalva maneuver
     
Marker Port against vessel wall
  • Small vessel diameter; if not 5 mm vessel, do not deploy
     
Side wall stick
  • Gently rotate device to move Marker Port off vessel wall
     
Low blood pressure
  • Slow drip is acceptable in vein
     
Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
     
Device not in vessel lumen
  • No flow can occur when Marker Port is near vessel lumen but not completely in the vessel
  • Continue inserting device until slow drip occurs

Lack of Haemostasis

Lack of haemostasis may be a result of incorrect order of knot advancement or tangled sutures.

Incorrect Order of Knot Advancement
Poor Flow Arterial
  • Advance Sutures in the order of deployment
Poor Flow Arterial
  • First Suture deployed is on the "bottom" or closest to the vessel. If Second Suture is tightened out of order, it may result in tangled Sutures and/or the inability to tighten the First Suture successfully
Poor Flow Arterial
Poor Flow Arterial
Tangled Sutures
  • After initial knot advancement of all Sutures, continue to tighten and lock each knot in the order deployed
  • Tightening and locking the Second Suture before the First Suture is completely secure can result in an incomplete or "partial" close
Lack of hemostasis
  • After Suture Deployment, a clamp is immediately placed on the Suture limbs. A gentle retraction is placed on the clamp until the Suture is taut. This removes all Suture slack from the tissue tract
Lack of hemostasis
  • If Suture slack is not removed, the Sutures can become tangled or pushed into the vessel during insertion of procedural sheaths and device exchanges
Lack of hemostasis suture slack

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