Contraindications - INVATEC Hippocampus Renales RX Stentsystem Gebrauchsanweisung

Hippocampus™
Renal RX Stent System
Description
The device brand name is Invatec Hippocampus™ Renal RX Stent System.
The generic device name is balloon-expandable stent system.
The device consists of a stainless steel balloon-expandable stent. The stent
is premounted on a rapid exchange stent delivery system (SDS) with a semi-
compliant balloon. The SDS contains 2 swaged radiopaque balloon markers
on the proximal and distal side of the balloon, aiding the exact placement of
the stent. This system is developed especially for the treatment of lesions in
the renal arteries, eg, ostial stenosis, dissections, or occlusions.
Nominal stent diameter and length are printed on the hub.
Stent Construction
The stents are made of laser-slotted tube, cut from 316 L stainless steel. The
closed-cell design is based on a uniform interconnection of monotype cells
without sharp joints or welding points. A specific design was developed to
minimize the shortening of the stent upon expansion and an ostial section to
flare the proximal section of the stent in the renal ostium.
Balloon Catheter Construction
The SDS is based on a rapid exchange balloon catheter design. The rapid
exchange section accepts 0.36 mm (0.014 in) guidewires. The controlled
compliance of the particular balloon material allows specific stent diameters
at specific pressures. Each balloon inflates the stent to its nominal diameter
and length at 8 bar. The working pressure range for the balloon is between
the nominal pressure and the rated burst pressure. All stents that distend at
pressures greater than the nominal pressure can present a maximum
statistical deviation of ±5%.
The length of each stent and balloon is specified. Two radiopaque swaged
(zero profile) markers on the distal catheter shaft indicate the dilating section
of the stent system and aid in exact stent placement. The catheter tip is
tapered and elongated to ease the entry into the renal arteries and to facilitate
the crossing of tight stenoses.
Indications for Use
The Hippocampus™ Renal Stent System is intended for use in the treatment
of stenoses in peripheral arteries, especially in patients with ostial renal artery
stenosis and/or insufficient results after PTRA in the distal segment of the
renal vessels, eg, >30% residual stenosis, dissection, obstruction due to
detached atherosclerotic plaque material, or reocclusion.

Contraindications

All contraindications of percutaneous transluminal renal artery angioplasty
(PTRA) apply to stent implantation. They include, but may not be limited to:
■
Inability to cross target lesion with a guidewire or limited access to the
target site
■
Patients with occlusion of both renal arteries
■
Patients with a history of coagulation disorders
■
Contraindication for anti-platelets and/or anticoagulation therapy
■
Angiographic evidence of fresh, unlysed, unorganized thrombus, or
embolic material in the target lesion
■
Diffuse vascular disease
■
Highly calcified lesions
■
Lesion within or adjacent to an aneurysm
■
Allergy to contrast media and/or to stainless steel, nickel, and chrome
alloys
Warnings
■
This device is designed and intended for SINGLE USE ONLY. DO NOT
RESTERILIZE AND/OR REUSE. Reuse or resterilization may create a
risk of contamination of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may
lead to injury, illness, or death of the patient. Reuse or resterilization may
compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness, and death. Invatec
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English
will not be responsible for any direct, incidental, or consequential damages
resulting from resterilization or reuse.
■
The device is intended for use as a unit. The stent must not be removed
from the delivery balloon to be crimped onto another balloon. Removing
the stent from its delivery balloon may damage the stent or lead to stent
embolization.
■
In case the device has to be removed together with the premounted stent
through a guiding catheter or sheaths, DO NOT PULL THE STENT
SYSTEM INTO THE CATHETER. Pull back the delivery system until the
proximal marker aligns with the distal tip of the guiding catheter or sheath
and pull back the guiding catheter together with the SDS. When the arterial
sheath is reached and the distal tip of the guiding catheter starts to
straighten while being pulled into the introducer sheath, the stent system
can be safely withdrawn from the artery. Pull it into the guiding catheter
and then into the sheath. Failure to follow this procedure may lead to loss
of parts or the entire stent in the vascular system.
■
To reduce the potential for vessel damage, the inflated diameter of the
stent should approximate the diameter of the vessel just proximal and
distal to the stenosis.
■
When the stent system is exposed to the vascular system, it should be
manipulated while under high-quality fluoroscopic observation.
■ Do not manipulate the stent system in inflated state. The position of the
stent system may only be changed with the guidewire in place.
■ If resistance occurs during manipulation, the cause must first be
ascertained by fluoroscopy, roadmapping, or digital subtraction
angiography (DSA) before the stent system is moved backward or
forward.
■
The guidewire may under no circumstances be moved during inflation of
the stent system.
■ The balloon must be completely deflated before pulling it out of the
expanded stent.
■ Do not exceed the rated burst pressure (RBP). The RBP is based on the
results of in vitro testing. At least 99.9% of balloons (with a 95%
confidence) will not burst at or below their RBP. Use of a pressure
monitoring device is recommended to prevent over pressurization.
■
Use only a mixture of contrast medium and saline solution to fill the balloon
(1:1). Never use air or any gaseous medium to inflate the balloon of the
stent system.
■
Use prior to Use By date.
Precautions
■ Only experienced interventionalists should carry out percutaneous
transluminal angioplasty (PTA) and stenting with this stent system. A
thorough understanding of the technical principles, clinical applications,
and risks associated with PTA and stenting is necessary before using this
product.
■
The device should be used with caution for procedures involving calcified
lesions due to their abrasive nature.
■ Allergic reactions to contrast medium should be identified before
treatment. The general technical requirements for catheter insertion must
be observed at all times. This includes flushing the components with
sterile, isotonic saline solution prior to use and the usual prophylactic,
systemic heparinization.
■
Catheter applications vary and the technique must be selected on the
basis of the patient's condition and the interventionalist's experience.
Caution: Larger models of the device may exhibit slower deflation times
particularly on long catheter shafts.
Potential Complications/Adverse Effects
The complications that may result from a balloon dilatation procedure include:
Puncture related
■
local hematoma
■
local hemorrhage
■
local or distal thromboembolic episodes
■
thrombosis
■ arteriovenous fistula
■ pseudoaneurysm
■ local infections
Dilatation related
■ dissection in the dilated artery wall
■ perforation of the artery wall
■ prolonged spasms
■ acute reocclusion necessitating surgical intervention
■
restenosis of the dilated artery