Merit Medical Bearing nsPVA - Manual (Page 5)

5
UFE Specific Precautions
• It is recommended that patients undergoing embolization of
leiomyoma uteri be provided a clear understanding of who will
provide post-procedure care prior to the embolization procedure.
• UFE should only be performed by physicians who have received
appropriate training for treatment of uterine leiomyomata (fibroids).
• There is an increased chance of retro-migration of BEARING nsPVA
Embolization Particles into unintended blood vessels as uterine
artery flow diminishes. Embolization should be stopped when the
vasculature surrounding the fibroid can no longer be visualized but
before complete stasis in the uterine artery.
• At the discretion of the physician, pneumatic compression devices may
be used for patients currently taking hormone therapy, uterine volume
>1000cc, and patients that are overweight, to lower the risk of deep vein
thrombosis.
INSTRUCTIONS FOR USE
Inspect packaging prior to use to ensure seal integrity for maintenance of
sterility.
1. Carefully evaluate the vascular network associated with the lesion using
high resolution imaging prior to beginning the embolization procedure.
2. Choose the appropriate size of BEARING nsPVA Embolization
Particles that best matches the pathology (i.e., vascular target/vessel
size) and provides the desired clinical outcome.
3. Choose a catheter based on the size of the target vessel and the
embolization particle size being used.
4. Introduce the delivery catheter into the target vessel according to
standard techniques. Position the catheter tip as close as possible to
the treatment site to avoid inadvertent occlusion of normal vessels.
5. To deliver BEARING nsPVA Embolization Particles: Remove the plunger
from a standard 30 mL syringe. Remove the screw-top cap from the vial and
transfer the BEARING nsPVA Embolization Particles into the barrel of the
syringe. Replace the plunger on the syringe. Aspirate 10 mL of contrast and
10 mL of 0.9% NaCl. To ensure proper hydration and suspension, gently
agitate the saline/contrast mixture of BEARING nsPVA Embolization
Particles and then wait 2-3 minutes, prior to injection. Attach the 30 mL
syringe to one port of a luer-lock 3-way stopcock. Attach a 1 mL or 3 mL
injection syringe to another port on the stopcock and, if desired, a catheter
may be attached to the remaining port on the stopcock. Draw the BEARING
nsPVA Embolization Particles saline/contrast mixture into the injection
syringe slowly and gently to minimize the potential of introducing air into
the system. Purge all air from the system prior to injection. Inject the
BEARING nsPVA Embolization Particles saline/contrast mixture into the
delivery catheter under fluoroscopic visualization using a slow pulsatile
injection while observing the contrast flow rate. If there is no effect on the
flow rate, repeat the delivery process with additional injections of the
BEARING nsPVA Embolization Particles saline/contrast mixture. Consider
using larger sized BEARING nsPVA Embolization Particles if the initial
injections do not alter the contrast flow rate. Exercise conservative
judgment in determining the embolization endpoint.
6. Upon completion of the treatment, remove the catheter while maintaining
gentle suction so as not to dislodge BEARING nsPVA Embolization Particles
still within the catheter lumen.
7. Apply pressure to the puncture site or use an arterial closure device until
hemostasis is complete.
8. Discard any open, unused BEARING nsPVA Embolization Particles.
The UFE specific end point is generally described as complete stasis or near
stasis, with the main uterine artery remaining patent, but with negligible
residual flow. This end point generally corresponds to an angiographic image
of a patent uterine artery with all its distal branches occluded. As with any
embolic particle, in order to avoid a false end point with early recanalization,
the embolization end point should be confirmed by leaving the catheter in the
uterine artery for approximately five minutes after the apparent conclusion
of the procedure. The end point should then be confirmed with an injection
of contrast and observation with fluoroscopy. Additional particles can then
be administered to reach the stated endpoint if flow restoration due to
redistribution is identified on this contrast injection.
Caution: “Clumping” of BEARING nsPVA Embolization Particles or catheter
obstruction may be a function of contrast dilution volume; ensure that enough
contrast is utilized such that BEARING nsPVA Embolization Particles are free
floating and not observed as aggregates.
STORAGE AND STERILITY
• BEARING nsPVA Embolization Particles are best stored at room temperature
in a dry and dark place in their original vial and packaging.
• Use by the date indicated on the labeling.
• Do not freeze.
• Do not resterilize.
UFE PATIENT COUNSELING INFORMATION:
• Patients should have a clear understanding prior to embolization of who
will provide their post-procedure care and who to contact in case of an
emergency after embolization.
• UFE candidates should have an understanding of the potential benefits,
risks, and adverse events associated with UFE. In particular, patients should
understand that there is a chance their fibroid-related symptoms will not
improve following UFE.
Rx Only Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
Single use only
Caution - Refer to Instructions For Use
Sterilized using GAMMA
All serious or life-threatening adverse events or deaths associated with use
of BEARING nsPVA Embolization Particles should be reported to the device
manufacturer.