NuMED CP STENT Instrucciones De Utilizacion página 3

P
RECAUTIONS
• Use of an inflation device with pressure gauge is highly recommended during this
procedure.
• The stent is rigid and may make negotiation through vessels difficult.
• Dilatation procedures should be conducted under fluoroscopic guidance with
appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help
prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and by
aspiration before proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced
against resistance. The cause of the resistance should be identified with fluoroscopy
and action taken to remedy the problem.
P C
OTENTIAL OMPLICATIONS
NOTE: Circumferential tear of the delivery balloon catheter prior to complete expansion of the
stent may cause the balloon to become tethered to the stent, requiring surgical removal. In case
of rupture of an adequately sized balloon after stent expansion, it can be withdrawn and a new
balloon catheter exchanged over a guidewire to complete expansion of the stent.
Cardiac catheterization carries certain risks. In addition, potential complications, and related
adverse effects associated with implants include, but are not limited to:
• Stent migration
• Stent Fracture
• Vessel ruptures
• Minor hematoma
• Distal thromboemboli
• Death
• Intraluminal thrombus
• Hematoma requiring repair
• Bleeding requiring transfusion
• Cell necrosis at the site of implant
MRI S I
AFETY NFORMATION
Nonclinical testing and modeling has demonstrated that the CP Stent is MR Conditional. A
patient with this device can be safely scanned in an MR system meeting the following condi-
tions:
• Static magnetic field of 1.5 T and 3 T
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0
W/kg for 15 minutes of scanning (Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the CP Stent
is expected to produce a maximum in vivo temperature rise of less than 2°C after 15 minutes of
continuous scanning.
MR image quality may be compromised if the area of interest is in the same area, or relatively
close to the position of the device. In nonclinical testing, the image artifact caused by the device
extends approximately 3 mm from the CP Stent when imaged with a spin echo pulse sequence
and 6 mm when imaged with a gradient echo pulse sequence and a 3 T MRI System. The lumen
of the device was obscured.
The presence of other implants or medical circumstances of the patient may require lower limits on
some or all of the above parameters.
/A E
DVERSE FFECTS
3
• Stent misplacement
• Pseudoaneurysm
• Stent misorientation
• Sepsis/infection
• AV fistula formation
• Transitory arrhythmia
• Cerebrovascular incident