Lead Locking Devices

LLD EZ and LLD

Indications

The Spectranetics Lead Locking Device, LLD, is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

Contraindications

Use of the LLD is contraindicated:

• When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life-threatening complication.
• When fluoroscopy is not available.
• In patients in whom superior venous approach cannot be used.
• When the proximal end of the pacing lead is not accessible to the operator.
• When the LLD will not fit into the inner lumen of the device to be extracted.

Warnings

Do not attempt to use the LLD without the availability of the Spectranetics Laser Sheath or other necessary lead removal tools. The LLD should be used only by physicians who are experienced in lead removal techniques. Do not insert more than one LLD into a lead lumen at a time. Lead removal devices should be used only at institutions with emergency cardiac surgical capabilities. Weigh the relative risks and benefits of intravascular lead removal procedures particularly when the item to be removed is of a dangerous shape or configuration, the likelihood of lead disintegration resulting in fragment embolism is high, and vegetations are attached to the lead body. When using the LLD, do not abandon a lead in a patient with an LLD still inside the lead. Severe vessel or endocardial wall damage may result from the stiffened lead or from fracture or migration of the abandoned device. Do not apply weighted traction to an inserted LLD as myocardial avulsion, hypotension or venous wall tearing may result. Be aware that a lead that has a J-shape retention wire that occupies its inner lumen (rather than being outside the coil) may not be compatible with the LLD. Insertion of the LLD into such a lead may result in protrusion and possible migration of the J-shape retention wire. When the LLD is in the body, it should be manipulated only under fluoroscopic observation. When marked calcification that moves with the device to be extracted is seen on fluoroscopy, particularly in the atrium, the availability of immediate surgical assistance is paramount if a problem presents itself as a result of the extraction procedure. Also, thoracotomy removal of the device(s) should be considered.

Precautions

For single use only. Do not resterilize and/or reuse. The LLD is intended to be used in one lead. Do not use the LLD: if the tamper-evident seal is broken; if the LLD has been damaged. When the LLD is in the body, it should be manipulated only under fluoroscopic observation. Due to rapidly evolving lead technology, this device may not be suitable for the removal of all types of leads. If there are questions or concerns regarding compatibility of this device with particular leads, contact the lead manufacturer. If selectively removing leads with the intent to leave one or more chronically implanted leads intact, these nontargeted leads must be subsequently tested to ensure that they were not damaged or dislodged during the extraction process.

Please see complete Instructions for Use before using the LLD / LLD E / LLD EZ 1.6 MB