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Disclaimer

Liverty™ TIPS Stent Graft

Indication for Use: The Liverty™ TIPS Stent Graft is indicated for the treatment of patients with cirrhosis and complications of portal hypertension.

Contraindications: There are no known contraindications for the Liverty™ TIPS Stent Graft.

Warnings:

  • Do not use the device after the “Use By” date specified on the label.
  • Do not use the device if the sterile packaging has been damaged or unintentionally opened prior to use.
  • The Liverty™ TIPS Stent Graft is supplied sterile (by ethylene oxide) and is intended for single use only. Do not resterilize and/or reuse the device. Reuse, resterilization, reprocessing, and/or repackaging may create a risk to the patient or user; may lead to infection or compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure; and/or may lead to injury, illness, or death of the patient. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death.
  • This device contains nitinol, an alloy made of nickel and titanium, and small components of tantalum and tungsten. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in this device, as well as the potential for allergy/hypersensitivity to these materials.
  • The device should not be used in the following situations, as the safety and performance have not been established. Patients with known allergy or sensitivity to contrast media, patients with uncontrolled systemic infection, septicemia or bacteremia. Patients who cannot be adequately pre-medicated.
  • The prophylactic use of antibiotics or anticoagulants is left to the discretion of the physician managing the patient.
  • If multiple stent grafts are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol (nickel-titanium alloy)).
  • The potential benefits of a TransjugularIntrahepatic Portosystemic Shunt (TIPS) procedure should be carefully weighed against the potential risks. Consult clinical practice guidelines to identify special considerations for patients with pre-existing conditions.

Precautions:

  • Prior to stent graft implantation, read the Instructions for Use.
  • The delivery system is not intended for any use other than stent graft deployment.
  • The stent graft implant cannot be repositioned after complete deployment of the covered stent graft segment.
  • A stent graft which was misplaced and extends too far into the vena cava or portal vein may cause thrombosis and/or difficulties during liver transplant surgery.
  • Once partially or fully deployed, the stent graft cannot be retracted or remounted onto the delivery system.
  • If unusual resistance is met during delivery system introduction, the system should be removed and another stent graft system should be used. Additional balloon dilatation may facilitate the passage of the delivery system.
  • Do not introduce or manipulate the delivery system without an appropriately-sized guidewire or fluoroscopic guidance.
  • Do not use a kinked delivery system.
  • Do not hold the dark brown catheter (H per Figure 2 in IFU), if visible during stent graft deployment since this must be free to move and slide into the beige stability sheath. Holding the dark brown catheter may lead to misplacement.
  • The stent graft must not be post-dilated beyond 10 mm in diameter. The uncovered distal end (in the portal vein) does not require post-dilatation.
  • When placing a shunt with a final diameter of ≤8 mm, the leading 20 mm of the covered stent graft segment must be additionally dilated with an 8 mm balloon for at least 25 seconds.
  • Higher deployment force may be encountered with longer length stent grafts.
  • Care must be taken when crossing the stent graft with catheters and sheaths after its placement to avoid the risk of stent graft dislodgement.
  • Placing the stent graft across a vessel side branch may impede blood flow and hinder or prevent future access and/or procedures.
  • Care must be taken to avoid puncture of, and stent graft placement within, a biliary stent if a stent is present.
  • Wait for 7 days after placement of the Liverty™ TIPS Stent Graft before performing surveillance ultrasound assessment of the shunt because air in the pores of the ePTFE may provide inaccurate information about the shunt patency.
  • One or more components of the device contain the following substance defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt (CAS No. 7440-48-4). Current scientific evidence supports that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.

Potential Complications and Adverse Events: Potential complications and adverse events associated with the use of the Liverty™ TIPS Stent Graft may include, but are not limited to, cardiac complications, cholestasis, embolism, hemorrhage, hepatic encephalopathy, infection, liver failure or dysfunction, occlusion, perforation, recurrence of ascites, stenosis or restenosis, thrombosis, tissue or organ injury, and vessel injury.

Please consult the Liverty™ TIPS Stent Graft Instructions for Use for complete product information, including full warnings, precautions, and potential complications and adverse events.

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