Merit Medical Bearing nsPVA - Manual (Page 3)

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EMBOLIZATION PARTICLES
NONSPHERICAL POLYVINYL ALCOHOL (NSPVA)
I N S T R U C T I O N S F O R U S E
PRODUCT DESCRIPTION
BEARING nsPVA Embolization Particles are irregularly-shaped,
biocompatible, hydrophilic, nonresorbable particles produced from
polyvinyl alcohol. These embolization particles are intended to provide
vascular occlusion or reduction of blood flow within target vessels upon
selective placement through a variety of catheters.
CONTENTS
• BEARING nsPVA Embolization Particles are packaged sterile in a glass vial
with a screw-top cap, packaged individually in a sterile peel pouch.
• Each vial contains 100 mg of BEARING nsPVA Embolization Particles,
packaged dry.
• Each sterile vial is intended for single patient use only. Do not resterilize.
Discard any opened, unused material.
SIZE RANGE & CATHETER COMPATIBILITY CHART
Order
Number Size Range (μm) Color Code Minimum Catheter ID
V100EP 45-150 Yellow 0.020” (508 μm)
V200EP 150-250 Purple 0.020” (508 μm)
V300EP 250-355 Dark Blue 0.020” (508 μm)
V400EP 355-500 Green 0.020” (508 μm)
V600EP 500-710 Orange 0.024” (610 μm)
V800EP 710-1000 Light Blue 0.027” (686 μm)
V1100EP 1000-1180 Red 0.040” (1016 μm)
INDICATIONS FOR USE
BEARING nsPVA Embolization Particles are used for the embolization of
peripheral hypervascularized tumors, including leiomyoma uteri and
peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of
leiomyoma uteri.
CONTRAINDICATIONS FOR ALL INDICATIONS
Use in the presence of:
1. Vascular anatomy or blood flow precludes stable, selective BEARING
nsPVA Embolization Particles or catheter placement
2. Vasospasm
3. Hemorrhage
4. Severe atheromatous disease
5. Feeding arteries smaller than distal branches from which they emerge
6. Collateral vessel pathways potentially endangering normal territories
during embolization
7. Arteries supplying the lesion not large enough to accept BEARING nsPVA
Embolization Particles
8. Vascular resistance peripheral to the feeding arteries precluding passage of
BEARING nsPVA Embolization Particles into the lesion
9. Large diameter arteriovenous shunts (i.e. where the blood does not pass
through an arterial/capillary/venous transition but directly from an artery to
a vein)
10. Arterial pulmonary vasculature
11. Patients intolerant to occlusion procedures
CONTRAINDICATIONS SPECIFIC TO UTERINE FIBROID
EMBOLIZATION (UFE)
1. Pregnant women
2. Suspected pelvic inflammatory disease or any other pelvic infection
3. Any malignancy of the pelvic region
4. Endometrial neoplasia or hyperplasia
5. Presence of one or more submucosal fibroid(s) with more
than 50% growth into the uterine cavity
6. Presence of pedunculated serosal fibroid as the dominant fibroid(s)
7. Fibroids with significant collateral feeding by vessels
other than the uterine arteries
POTENTIAL COMPLICATIONS FOR ALL INDICATIONS
Vascular embolization is a high-risk procedure. Complications may occur at
any time during or after the procedure, and may include, but are not limited
to, the following:
1. Postembolization syndrome
2. Foreign body reactions (i.e. pain, rash) necessitating medical
intervention
3. Allergic reaction to contrast media
4. Infection necessitating medical intervention
5. Complications related to catheterization (e.g. hematoma at the site of
entry, clot formation at the tip of the catheter and subsequent
dislodgment, vasospasm and nerve and/or circulatory injuries, which
may result in leg injury).
6. Undesirable reflux or passage of BEARING nsPVA Embolization Particles
into arteries adjacent to the targeted lesion or through the lesion into
other arteries or arterial beds.
7. Ischemia at an undesirable location
8. Incomplete occlusion of vascular beds or territories may give rise to
the possibility of postprocedural hemorrhage, development of
alternative vascular pathways, recanalization or recurrence of symptoms.
9. Vessel or lesion rupture and hemorrhage
10. Recurrent hemorrhage
11. Ischemic stroke or myocardial infarction
12. Death
13. Complications of misembolization include blindness, hearing loss, loss
of smell, paralysis, pulmonary embolism and death
POTENTIAL COMPLICATIONS SPECIFIC TO UFE
1. Postembolization syndrome
2. Vaginal Discharge
3. Tissue passage, fibroid sloughing or fibroid expulsion post-UFE
4. Temporary or permanent stopping of menstrual bleeding
5. Infection of the pelvic region
6. Endometrial atrophy with amenorrhea despite normal
ovarian function
7. Complications to pregnancy
8. Premature Ovarian Failure (i.e., menopause)
9. Necrosis of uterus, ovaries, buttocks, labia, cervix, and vagina
10. Vesicovaginal or vesicouterine fistula
11. Uterine Rupture
12. Post-UFE Intervention to remove necrotic fibroid tissue
13. Hysterectomy
14. Phlebitis
15. Deep vein thrombosis with or without pulmonary embolism
16. Transient hypertensive episode
17. Urinary Retention