Bard Peripheral Vascular LifeStent 5F Instructions For Use Manual page 4

• The safety and effectiveness of this device for use in treatment of in-stent restenosis has not been established.
• The G A ® Marking System is designed to be used as an additional reference tool to accompany the interventionalist's
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standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the
target lesion and prior to stent deployment or balloon inflation.
• If the G A ® location reference is on the brown moving sheath (Figure 9), the location reference will move relative to the
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introducer hub and stability sheath as soon as stent deployment has been initiated. DO NOT try to re-align the location
reference after stent deployment has been initiated. The green stability sheath should remain stationary relative to the
introducer and under tension throughout deployment.
POTENTIAl ADVERSE EVENTS
Complications and Adverse Events which may occur include, but are not limited to the following:
• Allergic/anaphylactoid reaction
• Amputation
• Aneurysm
• Angina/coronary ischemia
• Arterial occlusion/thrombus, near the puncture site
• Arterial occlusion/thrombus, remote from puncture site
• Arterial occlusion/restenosis of the treated vessel
• Arteriovenous fistula
• Arrhythmia
• Bypass Surgery
• Death related to procedure
• Death unrelated to procedure
• Embolization, arterial
• Embolization, stent
• Fever
• Hemorrhage/bleeding requiring a blood transfusion
• Hematoma bleed, remote site
• Hematoma bleed at needle, device path: nonvascular procedure
• Hematoma bleed, puncture site: vascular procedure
• Hypotension/hypertension
• Incorrect positioning of the stent requiring further stenting or surgery
• Intimal injury/dissection
• Ischemia/infarction of tissue/organ
• Liver failure
• Local infection
• Malposition (failure to deliver the stent to the intended site)
• Open surgical repair
• Pain
• Pancreatitis
• Pulmonary embolism/edema
• Pneumothorax
• Pseudoaneurysm
• Renal failure
• Respiratory arrest
• Restenosis
• Septicemia/bacteremia
• Stent fracture
• Stent migration
• Stroke
• Vasospasm
• Venous occlusion/thrombosis, remote from puncture site
• Venous occlusion/thrombosis, near the puncture site
MAGNETIC RESONANCE IMAGING (MRI) COMPATIBIlITY
Non-clinical testing has demonstrated that the L S
ife
patients with the L S ® Vascular Stent can be scanned safely, immediately after placement of this implant, under the
ife tent
following conditions:
• Static magnetic field of 1.5 Tesla or 3 Tesla.
• Spatial gradient field of 2500 Gauss/cm or less.
• Maximum whole-body-averaged specific absorption rate (SAR) of 1 W/kg for 15 minutes of scanning. For landmarks superior
of the umbilicus, a whole body SAR up to 2 W/kg may be applied.
• In a configuration where the patients legs are not in contact with each other.
3.0 Tesla Temperature Rise
Under the scan conditions defined above, the L S
ife tent
patient of 2.7 °C after 15 minutes of continuous scanning.
1.5 Tesla Temperature Rise
Under the scan conditions defined above, the L S
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patient of 3.0 °C after 15 minutes of continuous scanning.
Image Artifact
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the
stent. Artifact tests were performed according to ASTM F2119-07. In non-clinical testing, the image artifact caused by the device
extends approximately 3 mm from the L S ® Vascular Stent when imaged with a spin echo sequence and 8 mm when imaged
ife tent
with a gradient echo sequence in a 3.0 Tesla MRI system. The lumen was obscured.
Additional Information
The L S ® Vascular Stent has not been evaluated in MRI systems other than 1.5 or 3.0 Tesla. The heating effect in the MRI
ife tent
environment for fractured stents is not known. The presence of other implants or the health state of the patient may require
reduction of the MRI limits listed above.
The following information is provided in the packaging for the physician to provide their patients:
• A Patient Implant Card, within the Instructions for Use, that is used to record and disseminate information about the patient
and the stent.
HOW SUPPlIED
STERIlE AND FOR SINGlE USE ONlY. The L S
ife tent
is non-pyrogenic.
CONTENTS for one (1) L S ® 5F Vascular Stent System:
ife tent
• One (1) L S ® 5F Vascular Stent System
ife tent
• One (1) Instructions for Use including one (1) Patient Implant Card
STORAGE: Store in a cool, dark, dry place. Keep away from sunlight. DO NOT use after the „ Use By" date specified on the label.
DISPOSAl INSTRUCTIONS: After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.
DIRECTIONS FOR USE
A. Pre-Deployment Procedure
1. Inject Contrast Media
Perform an angiogram using standard technique.
2. Evaluate and Mark Target Site
Fluoroscopically evaluate and mark the target site, observing the most distal diseased or obstructed segment.
4
® Vascular Stent is MR Conditional. Based upon the preclinical testing,
tent
® Vascular Stent is expected to produce a maximum temperature rise in the
® Vascular Stent is expected to produce a maximum temperature rise in the
® 5F Vascular Stent System is supplied sterile (by ethylene oxide gas) and