GORE CARDIOFORM - Reloading the Occluder; Removing Occluder After Locking

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FIGURE 7: Occluder Locking
FIGURE 8: Occluder Release
FIGURE 8a: Retrieval Cord Lock Release
FIGURE 8b: Retrieval Cord Removal
G. Reloading the Occluder Before Occluder Locking
1. Reload the Occluder by pushing the Slider up and then to the right until the
desired portion of the Occluder discs is reloaded or until the Slider stops, if
complete disc reloading is desired (Figure 4a).
2. If desired, complete Occluder reloading by pushing the Slider down and
then to the right until it stops (Figure 4b). Ensure that the Delivery Catheter
tip remains across the defect to maintain defect access.
3. Refer to Section E, “Occluder Deployment” to re-deploy the Occluder.
• If desired device placement cannot be achieved after multiple
deployment attempts, consideration should be given to minimize the
patient’s exposure to radiation and prolonged anesthesia time. If the
patient’s septal anatomy is determined to be unsuitable for the GORE®
CARDIOFORM Septal Occluder, alternative treatment options such as
other devices or surgical closure of the defect should be considered.
H. Removing the Occluder with the Retrieval Cord After Occluder
Locking
1. Unscrew the Retrieval Luer, hold the Delivery Catheter in place and
withdraw the Handle until the Occluder has unlocked (Figure 9). This step
requires that the Delivery Catheter is sufficiently spaced away from the
Occluder to permit full extension of the Lock Loop.
2. Continue to withdraw the Handle to pull the entire Occluder into the
Delivery Catheter. Do not use excessive force in an attempt to withdraw
all of the Occluder into the Delivery Catheter. Doing so could cause the
Retrieval Cord to break or result in Occluder damage.
• The operator must ensure that the Occluder does not catch on the
Delivery Catheter tip or introducer sheath. If the Lock Loop or eyelet
catch and the Delivery System is forcibly retracted, the Retrieval Cord
or Occluder frame is at risk of damage.
3. If necessary, remove the introducer sheath and Occluder together.
• If the Occluder is removed, it should be disposed of and a new
Occluder should be used.
Note that without a hemostatic valve at the Delivery Catheter
proximal end, care should be taken to avoid air entry or blood loss if
the Occluder is completely removed from the Delivery Catheter.