Potential Complications; Potential Complications Specific To Ufe; Warnings And Precautions - Boston Scientific Contour Mode D'emploi

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

Complications specific to embolization include, but may not be limited to:
1. Foreign body reactions (i.e. pain, rash) necessitating medical intervention
2. Allergic reaction to contrast media
3. Infection necessitating medical intervention
4. 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)
5. Undesirable reflux or passage of Contour™ Embolization Particles into arteries
adjacent to the targeted lesion or through the lesion into other arteries or
arterial beds
6. Ischemia at an undesirable location
7. Incomplete occlusion of vascular beds or territories may give rise to the possibility
of post procedural hemorrhage, development of alternative vascular pathways,
recanalization or recurrence of symptoms
8. Vessel or lesion rupture and hemorrhage
9. Recurrent hemorrhage
10. Ischemic stroke or myocardial infarction
11. 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. Uterine/Ovarian necrosis
10. Uterine Rupture
11. Post-UFE Intervention to remove necrotic fibroid tissue
12. Hysterectomy

warnInGS anD PrECaUTIOnS

Warnings Applicable to All Peripheral Indications
• PRIOR TO EMBOLIZATION, PROSPECTIVE PATIENTS OR THEIR REPRESENTATIVES
MUST BE PROVIDED AN INFORMED CONSENT DESCRIBING THE POSSIBLE
COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. WRITTEN
ACKNOWLEDGMENT IS WARRANTED.
• The safety and effectiveness of Contour Embolization Particles for neurovascular
use have not been established.
• As with any embolization device, patient injury, permanent disability or death may
occur as a result of its use.
• Vascular occlusion should only be performed by physicians possessing skilled
interventional occlusion experience in the territory intended to be embolized.
• A thorough evaluation of a patients medical condition, vascular pathways and
the desired embolization goal is necessary to achieve successful occlusion.
This evaluation should include baseline angiography to determine the presence
of potentially dangerous collateral pathways. Do not proceed with embolization
unless these pathways can be protected.
• Do not use if protective sterile packaging is opened or damaged.
• Smaller Contour Embolization Particles may be more likely to result in ischemic
infarction because of the potential to block vessels at the precapillary level;
however, Contour Embolization Particles of all sizes share this potential.
• Typically the artery will accept less Contour Embolization Particles as the
treatment progresses. Proximal slowing or termination of Contour Embolization
Particles passage may occur when the vessel or malformation is occluded by
prior Contour Embolization Particles, or in the presence of severe atheromatous
disease. Continued infusion may result in inadvertent reflux into critical arteries,
creating the potential for undesirable ischemic infarction.
• Exercise conservative judgment in determining embolization endpoint. Terminate
infusion before complete vessel occlusion has occurred.
• Avoid the use of a tapered tip delivery catheter. The Contour Embolization
Particles may lodge at the catheter tip creating an obstruction.
• "Clumping" of Contour Embolization Particles or catheter obstruction may be a
function of contrast dilution volume; ensure that sufficient volume of the appropriate
contrast/saline mix is utilized such that Contour Embolization Particles are free floating
and not observed as aggregates.
• Should catheter obstruction occur, remove the catheter from the patient. Do not
use forceful injection, guidewires or other instruments to dislodge the blockage.
Do not continue using a catheter which has been obstructed as damage to the
device may have occurred.
• Incomplete occlusion of vascular beds or territories may give rise to the possibility
of post procedural hemorrhage, development of alternative vascular pathways, or
recurrence of symptoms.
• Postprocedural patient follow-up to assess the continued level of vascular
occlusion is necessary. Angiography may be indicated.
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