Magnetic Resonance Imaging (Mri); Adverse Events - Boston Scientific Epic Mode D'emploi

• When multiple stents are required, if placement results in metal to metal
contact, stent materials should be of similar composition and overlapped at
least 5 mm.
• The stent delivery system is not intended for arterial blood monitoring.
• Prior to completion of the procedure, utilize fluoroscopy to ensure proper
positioning of the stent. If the target lesion is not fully covered, use additional
stents as necessary to adequately treat the lesion.
• The minimally acceptable sheath French size is printed on the package label.
Do not attempt to pass the stent delivery system through a smaller size sheath
introducer than indicated on the label.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should
be attempted.
• In the event of complications such as infection, pseudoaneurysms or
fistualization, surgical removal of the stent may be required. Standard surgical
procedure is appropriate.
• Recrossing a stent with adjunct devices must be performed with caution.
• Premature removal of the safety lock may result in an unintended deployment
of the stent.

MaGnETIC rESOnanCE IMaGInG (MrI)

Through non-clinical testing, the Epic™ Stent has been shown to be MR Conditional,
at field strengths from 1.0 to 3.0 Tesla, with maximum whole body averaged specific
absorption rates (SAR) and maximum continuous MRI scan times stated in the
table below. Other conditions of the testing include the following:
• Spatial gradient fields of 70 mT/cm or less
• A rate of change of magnetic field (dB/dt) of 60 T/s or less
The following table lists the conditions that produce a maximum temperature rise
of .0 degrees C.
Maximum continuous MRI scan time based on 1.0 to 1. W/Kg SAR Level
Total Stent
length Static Magnetic
(including field (Tesla)
overlap) (mm)
1.0
10 1.5
3.0
1.0
180
1.5
1.0
30 1.5
3.0
The RF heating testing was conducted on a Philips NT Intera
Philips Intera 1.5 Tesla scanner, and a Siemens Magnetom Trio
RF heating with scanners other than those listed is unknown.
The effect of heating in the MRI environment for stents with simulated fractures
has been tested and found to be similar to single stents.
Maximum
Sar (w/Kg) Continuous MrI
Scan Time
1. 15 min.
1.0 10 min. 5 sec.
1.1 15 min.
1.0 1 min. 5 sec.
1.0 3 min.
1.0 1 min. 15 sec.
1.0  min. 30 sec.
1.1 15 min.
1.0 Tesla scanner, a
TM
3 Tesla scanner.
TM
MRI at 3T or less may be performed immediately following the implantation of
the Epic Stent. The Epic Stent should not migrate in this MRI environment. This
stent has not been evaluated to determine if it is MR Conditional beyond these
conditions.
MR imaging quality may be compromised if the area of interest is in the exact same
area or relatively close to the position of the stent.

aDVErSE EVEnTS

Procedures requiring percutaneous catheter introduction should not be attempted
by physicians unfamiliar with the possible complications. Complications may occur
at any time during or after the procedure. Potential complications may include, but
are not limited to:
• Abscess
• Acute/subacute stent thrombosis
• Allergic reaction (to drug, contrast, device, or other)
• Amputation
• Aneurysm
• Angina/coronary ischemia
• Arrhythmia
• AV fistula
• Death
• Drug reactions
• Embolization (air, plaque, thrombus, device, or other)
• Entanglement of delivery system in deployed stent
• GI bleeding from anticoagulant/antiplatelet medication
• Hemorrhage/hematoma
• Hypotension/hypertension
• Myocardial Infarction (MI)
• Need for urgent intervention or surgery
• Pseudoaneurysm formation
• Renal insufficiency or failure
• Restenosis of stented artery
• Rupture of the retroperitoneum or neighboring organ
• Sepsis/infection
• Stent fracture
• Stent migration
• Stent misplacement/jumping
• Stroke
• Thrombus
• Tissue necrosis/ischemia
• Vasospasm
• Vessel injury (perforation, dissection, intimal tear, rupture, or other)
• Vessel occlusion

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