Bead Block™ Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATION

Bead Block microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).

CONTRAINDICATIONS

  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheter placement or injection of embolics
  • Presence or likely onset of vasospasm
  • Presence or likely on set of hemorrhage
  • Presence of severe atheromatous disease
  • Presence of lesion/tumor-feeding vessel with diameter smaller than any distal vessel(s) branching from it
  • Presence of patent extra-to-intracranial anastomoses or shunts
  • Presence of collateral vessel pathways potentially endangering normal territories during embolization
  • Presence of end arteries leading directly to cranial nerves
  • Presence of arteries supplying the lesion/tumor not large enough to accept Bead Block microspheres
  • Vascular resistance peripheral to the feeding arteries precluding passage of Bead Block microspheres into the lesion/tumor
  • Do not use Bead Block microspheres in the following applications:
    • Embolization of large diameter arteriovenous shunts (i.e. where the blood does not pass through the arterial/capillary/venous transition but directlyfrom artery to vein)
    • The pulmonary arterial vasculature
    • Any vasculature where the use of Bead Block could pass directly into the internal carotid artery, the central circulatory system or other non-target territories

    Uterine Fibroid Embolisation (UFE) SPECIFIC CONTRAINDICATIONS

  • Pregnant women
  • Active or suspected pelvic inflammatory disease
  • Malignancy of the pelvic region
  • Endometrial neoplasia or hyperplasia
  • Presence of submucosal fibroids with greater than 50% growth into the uterine cavity
  • Presence of pedunculated serosal fibroid as the dominant fibroid(s)
  • Fibroids with significant collateral feeding by vessels other than the uterine arteries

WARNING 

Studies have shown that Bead Block microspheres do not form aggregates and, as a result, penetrate deeper into the vasculature as compared to similarly sized PVA particles. Care must be taken to choose a larger sized Bead Block Embolic Agent when embolizing arteriovenous malformations with large shunts to avoid passage of the microspheres into the pulmonary or coronary circulation.

The color of the Bead Block microspheres could be visible through the skin if injected into arteries feeding superficial tissues.

Warnings about UFE and Pregnancy:

  • There are no long term data on the effects of UFE on the ability to become pregnant and carry a fetus to term, and on the development of the fetus
  • This procedure should only be performed on women who do not intend future pregnancy
  • Women who become pregnant following UFE may be at increased risk for the following:
    • Postpartum hemorrhage
    • Abnormal placentation
    • Preterm delivery
    • Caesarean delivery
    • Abnormal presentation at birth
    • Devascularization of the uterine myometrium resulting from UFE may increase the risk of uterine rupture of women who subsequently become pregnant following UFE

OTHER UFE WARNINGS

  • When using Bead Block for uterine fibroid embolization, do not use beads smaller than 700 microns
  • An appropriate gynecologic work-up should be performed on all patients presenting for embolization of uterine fibroids (e.g. gynecologic history, fibroid imaging, endometrial sampling to rule out carcinoma in patients with abnormal menstrual bleeding)
  • The diagnosis of uterine sarcoma could be delayed by taking a non-surgical approach (such as UFE) to treating fibroids. It is important to pay closeattention to warning signs for sarcoma (e.g., rapid tumor growth, postmenopausal with new uterine enlargement, MRI findings) and to conduct a morethorough work-up of such patients prior to recommending UFE. Recurrent or continued tumor growth following UFE should be considered a potential warning sign for sarcoma and surgery should be considered

POTENTIAL COMPLICATIONS

  • Undesirable reflux or passage of Bead Block microspheres into normal arteries adjacent to the targeted lesion/tumor or through the lesion/tumor into other arteries or arterial beds
  • Non-target embolization
    • Pulmonary embolism
    • Pancreatitis
  • Ischaemia at undesirable locations
  • Post embolization syndrome
  • Capillary bed saturation and tissue damage
  • Ischaemic stroke or ischaemic infarction
  • Vessel or lesion/tumor rupture and hemorrhage
  • Neurological deficits including cranial nerve palsies
  • Liver abscess
  • Vasospasm
  • Death
  • Recanalisation
  • Foreign body reactions necessitating medical intervention
  • Infection necessitating medical intervention
  • Clot formation at the tip of the catheter and subsequent dislodgement

UFE SPECIFIC POTENTIAL COMPLICATIONS

Potential post procedure complications include:

  • Abdominal pain
  • Discomfort
  • Fever
  • Nausea
  • Constipation
  • Premature ovarian failure (i.e. menopause)
  • Amenorrhea
  • Infection of the pelvic region
  • Uterine/ovarian necrosis
  • Local vascular inflammation
  • Deep vein thrombosis with or without pulmonary embolism
  • Vaginal discharge
  • Tissue passage, fibroid sloughing, or fibroid expulsion post UFE
  • Post-UFE intervention to remove necrotic fibroid tissue
  • Vasovagal reaction
  • Transient hypertensive episode
  • Hysterectomy

 

PI-719210-AA

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