COOK Medical FORMULA 418 Gebrauchsanweisung Seite 5

PRECAUTIONS
General
• Implantation of the stent should be performed only by physicians who have received adequate training. Adequate
training consists of specific training in vascular stenting techniques and procedures under the supervision of an
interventional physician experienced in vascular stent implantation.
• Stent placement should only be performed at hospitals where emergency artery bypass graft surgery can be
readily performed.
• Subsequent restenosis may require redilatation of the arterial segment containing the stent. The long-term
outcome following repeat dilatation of an endothelialized Formula 418 Vascular Stent is unknown at present.
Stent Placement
• Manipulation of the Formula 418 Vascular Balloon-Expandable Stent System requires fluoroscopic control.
• The stent is preloaded on its delivery balloon and should not be removed. Do not attempt to place stent on
another balloon catheter for deployment.
• Deploy the stent over a wire guide not exceeding 0.018 inch diameter.
• DO NOT wipe or clean stent or catheter with organic solvent (i.e. isopropyl alcohol).
• DO NOT expose catheter to temperatures above 54°C (130°F).
• DO NOT use power injection systems with the delivery system.
• DO NOT rotate any part of the system during deployment.
• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is particularly
important during removal of the catheter from packaging, placement over the wire guide and advancement
through the large-bore Tuohy-Borst "Y" adapter and guiding catheter hub.
• Do not pre-inflate balloon prior to stent deployment (See Preparation of Balloon Catheter section in these
Instructions for Use).
• Use only the appropriate balloon inflation medium. The standard inflation medium is a 1:1 mixture of contrast
medium and normal saline. Do not use air or any gaseous substance as a balloon inflation medium.
• Expansion of the stent should not be undertaken if the stent is not properly positioned in the vessel (See Removal
of Unexpanded Stent section in these Instructions for Use).
• Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure as indicated on the
product label. Use of pressures higher than specified on the product label may result in a ruptured balloon, with
possible intimal damage and dissection.
• Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent and may cause acute
closure of the vessel, requiring additional intervention (further dilatation or placement of additional stents).
• Use prior to the expiration date on the package label.
• Intended for one-time use (Do not re-sterilize).
• The use of mechanical atherectomy devices within an implanted stent may cause damage to the stent.
• Repositioning of the device after deployment is not possible.
MAGNETIC RESONANCE IMAGING
Non-clinical testing has demonstrated that the Formula 418 Vascular Stent is MR Conditional according to ASTM
F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
A patient with this stent can be scanned safely anytime after placement under the following conditions.
• Static magnetic field of 3-Tesla or 1.5-Tesla
• Maximum spatial magnetic gradient of 720 Gauss/cm or less
• Product of the spatial gradient and the static magnetic field of 21.6 T2/m or less
• MR system reported whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg or less for 15 minutes of
scanning
Non-clinical evaluation was conducted in an MR system (Excite, General Electric Healthcare) with a maximum spatial
magnetic gradient field of 720 Gauss/cm as measured with a gaussmeter in the position of the static magnetic
field pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual). In non-clinical
testing, a single and two overlapped Formula 7 mm x 20 mm stents produced a maximum temperature rise of
2.6 °C and 3.3 °C, respectively, during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 3 Tesla
MR system (3 Tesla/128 MHz, Excite, Software G3.0-052B, General Electric Healthcare) at an MR system reported
whole-body-averaged SAR of 3.0 W/kg (associated with a calorimetry measured whole-body-averaged value of
2.8 W/kg).
The effect of heating in the MRI environment for stents with fractured struts is unknown.
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