INDICATIONS, SAFETY, AND WARNINGS Concerto Versa Detachable Coil

Note: Safety information provided is for the United States.  Please refer to your region’s Instructions for Use for specific details.

Reference Statement:

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

Results may vary. Not all patients achieve the same results.

CAUTION: Federal (USA) law restricts these devices to sale, distribution, and use by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

Potential Complications:

Potential complications include, but are not limited to: 

• Adverse reaction to antiplatelet/anticoagulation agents
• Access site complications: hematoma, hemorrhage, pain
• Cardiac complications: arrhythmia, myocardial infarction
• Complications due to radiation exposure: alopecia, skin reddening, ulcers, skin discoloration, pain, neoplasia, cancer
• Death
• Device malfunctions: coil stretching, friction, fracture, breakage, migration, premature detachment, non-detachment
• Neurological deficits or dysfunctions: stroke, infarction, transient ischemic attack, emotional changes
• Reactions due to anesthesia: nausea, aspiration and organ failure
• Reaction to device materials: hypersensitivity, hemolysis, fever, shock, foreign body reaction
• Systemic complications: infection, pain, shock, fever, inflammation, toxicity, organ failure, nerve damage, necrosis, hypertension, hypotension, hematoma, hemorrhagic complications, edema
• Thromboembolic complications: ischemia, occlusion, embolism, endoleak
• Therapeutic response decreased
• Vascular complications: vasoconstriction, stenosis, dissection, perforation, fistula formation, occlusion, endoleak