Warnings; Precautions; Adverse Events; Individualization Of Treatment - Spectranetics LLD Instrucciones De Uso

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.
4.

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.
-Vegetations are attached to the lead body.
When using the LLD:
Do not abandon a lead in a patient with a 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.
Excessive applied traction forces may impact the LLD's ability to disengage from a
lead.
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.
Do not use a Metal Reinforced Flexible Dilator Sheath to apply myocardial
countertraction.
When the LLD is in the body, it should be manipulated only under fluoroscopic
observation.
Maintain appropriate traction on the LLD and device being extracted during
advancement of the Spectranetics Laser Sheath.
When marked calcification that moves with the device to be extracted is seen on
fluoroscopy, particularly in the atrium, the availability of imm ediate 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.
5.

Precautions

Thoroughly review appropriate package inserts for the Spectranetics Laser
®
Sheath (SLS ) before attempting to use the SLS
For single use only. Do not resterilize and/or reuse. The LLD is intended to be used
in one lead.
DO NOT resterilize or reuse this device, as these actions can compromise device
performance or increase the risk of cross-contamination due to inappropriate
reprocessing.
Reuse of this single use device could lead to serious patient injury or death and voids
manufacturer warranties.
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.
Prior to the procedure, consider the size of the lead to be extracted in relation to the
size of the Lead Extraction Devices and LLD. Any device used over the lead to be
extracted must have an ID greater than the target lead maximum outer diameter.
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 procedure.
6.

Adverse Events

Commonly observed adverse events during lead removal procedures have included:
Hemopericardium Tamponade
Hemothorax
Thrombosis
Tricuspid Regurgitation
Infection
Death
P 0 0 4 7 7 7 - 0 2
1 3 D e c 1 1
( 2 0 1 1 - 1 2 - 1 3 )
®
with the LLD.
The following adverse events or conditions may also occur during lead removal (listed
in alphabetical order):
bacteremia
low cardiac output
migration of lead fragments
migration of vegetation
myocardial avulsion
premature ventricular contractions
pulmonary embolism
stroke
venous avulsion
ventricular tachycardia
Additional information may be found in the articles referenced in the bibliography.
7.

Individualization of Treatment

Weigh the relative risks and benefits of intravascular lead removal procedures in cases
where:
The lead to be removed has a sharp bend or evidence of fracture;
The lead shows evidence of insulation disintegration raising the concern of
pulmonary embolism;
Vegetations are attached to the lead body.
When an outer sheath is left in place following lead removal, it may then be used as a
conduit to facilitate the implantation of a new lead.
The sheath tip should be either (a) fully into the atrium, or (b) retracted into the
brachiocephalic vein.
Placing the outer sheath tip at the SVC-atrial junction risks damage to this delicate
area during subsequent procedures, such as moving the outer sheath or implanting a
new lead and is thus not recommended.
It is vital that appropriate traction be maintained on the lead being extracted during all
extraction attempts. If appropriate levels of traction cannot be maintained to offset the
counter-pressures that distort the lead body, changing to an alternative extraction
procedure should be considered.
When marked calcification that moves with the lead to be extracted is seen on
fluoroscopy, particularly in the atrium, the availability of immediate surgical assistance
is paramount if a problem presents itself because of the extraction procedure. Also, an
indication for thoracotomy removal of the lead(s) should be considered.
8.

Operator's Manual

8.1

Sterilization

For single use only. Do not re-sterilize and/or reuse.
NON-PYROGENIC
The Spectranetics LLD, Accessory Kit, and Lead Cutter are supplied sterile and Non-
Pyrogenic. Sterility is guaranteed only if the package is unopened and undamaged.
8.2 Device / Packaging Care
60°C / 140°F
Store devices in a dry cool place (Below 60° C / 140°F) until use.
8.3

Inspection Prior to Use

Before use, visually inspect the sterile package to ensure that seals have not been
broken. All equipment to be used for the procedure, including the LLD, should be
examined carefully for defects. Examine the LLD for bends, kinks or other damage.
Do not use if it is damaged.
8.4

Procedure Set Up

LLD Preparations:
1. Using sterile technique, open the sterile package.
Patient preparations:
1. Obtain a thorough patient history, including patient blood type. Appropriate blood
products should be readily available.
2. Ascertain the manufacturer, model number and implant date of the lead to be
removed. Perform radiographic / echo-cardiographic evaluation of lead condition,
type and position.
3. Use a procedure room that has fluoroscopy, pacing equipment, defibrillator, and
thoracotomy and pericardiocentesis trays.
4. Prep and drape the patient's chest for possible thoracotomy; prep and drape the
patient's groin for a possible femoral approach extraction procedure. If a femoral
approach becomes necessary, the LLD is contraindicated.
5. Establish back-up pacing as needed.
9.

Instructions for Use of the LLD

NOTE: "LLD" refers to all LLD devices (#1, #2, #3, E, and EZ).
WARNING: Do not abandon a lead in a patient with a LLD still in place. Severe vessel
or endocardial wall damage may result from the stiffened lead or from fracture or
migration of the abandoned LLD body.
WARNING: 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.
WARNING: Excessive applied traction forces may impact the LLD's ability to
disengage from a lead.
WARNING: Do not apply weighted traction to an inserted LLD as myocardial avulsion,
hypotension, or venous wall tearing may result.
1. After the proximal end of the lead has been exposed, sutures and tie-down
materials removed, and the proximal fittings (if present) cut off, using the
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