Thoracic Device Radiographs; Mri Information; Additional Surveillance And Treatment; Release Troubleshooting - COOK Medical ZENITH ALPHA Mode D'emploi

Table 4 — Acceptable Imaging Protocols
IV contrast
Acceptable machines
Injection volume
Injection rate
Injection mode
Bolus timing
Coverage - start
Coverage - finish
Collimation
Recon struction
Axial DFOV
Post-injection runs

11.3 Thoracic Device Radiographs

The following views are required:
• Four films: supine-frontal (AP), cross-table lateral, 30° RPO, and 30° LPO.
• Record the table-to-film distance and use the same distance at each
subsequent examination.
• Ensure entire device is captured on each single image format lengthwise.
• The middle photocell, thoracic spine technique, or manual technique should
be used for all views to ensure adequate penetration of the mediastinum.
If there is any concern about the device integrity (e.g., kinking, stent
breaks, barb separation, relative component migration), it is recommended
to use magnified views. The attending physician should evaluate films for
device integrity (entire device length, including components) using
2-4X magnification visual aid.

11.4 MRI Information

Nonclinical testing has demonstrated that the Zenith Alpha Thoracic
Endovascular Graft is MR Conditional. A patient with this endovascular graft can
be scanned safely after placement under the following conditions.
• Static magnetic field of 1.5 or 3.0 Tesla.
• Spatial magnetic gradient of 1600 Gauss/cm or less.
• The product of the spatial gradient and static magnetic field should not
exceed 48.0 T 2 /m.
• 1.5 and 3.0 Tesla Systems: Maximum whole-body-averaged specific
absorption rate (SAR) of 2 W/kg (Normal Operating Mode) for 15 minutes of
scanning (i.e., per scanning sequence).
Static Magnetic Field
The static magnetic field under consideration is the static magnetic field
pertinent to the patient (i.e., outside of scanner covering, accessible to a patient
or individual).
MRI-Related Heating
1.5 Tesla Temperature Rise
In nonclinical testing, the Zenith Alpha Thoracic Endovascular Graft produced a
maximum temperature rise of 1.7°C during 15 minutes of MR imaging (i.e., for
one scanning sequence) performed in a MR 1.5 Tesla System (Siemens Medical
Solutions, Malvern, PA, Software Numaris/4) at an MR system reported whole-
body-averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole-
body-averaged value of 2.1 W/kg).
Scaling of the SAR and observed heating indicates that a SAR of 2 W/kg would
be expected to yield a localized temperature rise of 1.2°C.
3.0 Tesla Temperature Rise
In nonclinical testing, the Zenith Alpha Thoracic Endovascular Graft produced
a maximum temperature rise of 2.1°C during 15 minutes of MR imaging (i.e.,
for one scanning sequence) performed in a MR 3.0 Tesla System (GE Electric
Healthcare, Milwaukee, WI, Software 14X.M5) at an MR system reported whole-
body-averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole-
body-averaged value of 2.7 W/kg).
Scaling of the SAR and observed heating indicates that a SAR of 2 W/kg would
be expected to yield a localized temperature rise of 1.4°C.
Image Artifact
MR image quality may be compromised if the area of interest is within the
lumen or within approximately 5 mm of the position of the Zenith Alpha
Thoracic Endovascular Graft, as found during nonclinical testing using the
sequences: T1-weighted, spin echo and gradient echo pulse in a 3.0 Tesla
MR system (Excite, General Electric Healthcare, Milwaukee, WI). Therefore,
optimization of MR imaging parameters to compensate for the presence of this
device may be necessary.
I-ALPHA-TAA-1306-436-01
Non-contrast
No
Spiral CT or high performance MDCT
capable of > 40 seconds
n/a
n/a
n/a
n/a
Neck
Diaphragm
<3 mm
2.5 mm throughout - soft algorithm
32 cm
None
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners:
Mail:
Phone:
Fax:
Web:

11.5 Additional Surveillance and Treatment

(Refer to section 4, WaRNINGS aND PRECaUTIoNS)
Additional surveillance and possible treatment is recommended for:
• Type I endoleak
• Type III endoleak
• Aneurysm or ulcer enlargement, >5 mm of maximum aneurysm diameter or
ulcer depth (regardless of endoleak status)
• Migration
• Inadequate seal length
Consideration for reintervention or conversion to open repair should include
the attending physician's assessment of an individual patient's comorbidities,
life expectancy, and the patient's personal choices. Patients should be
counseled that subsequent reinterventions, including catheter-based and open
surgical conversion, are possible following endograft placement.

12 RELEASE TROUBLESHOOTING

NoTE: Technical assistance from a Cook product specialist may be obtained by
contacting your local Cook representative

12.2.1 Difficulty removing the release wires

Turning the rotation handle pulls the release wire back, releasing the stent graft
attachment to the introducer. If the stent graft is not completely released, it is
possible to disassemble the rotation handle by following the steps below.
1. Use surgical forceps to pull the back-end clips out (figs. 17 and 18) and
remove the back-end cap (fig. 19).
2. Slide the rotation handle backward to pull the release wires out (figs. 20
and 21).
NoTE: If extreme force is needed, the release wires may be wound around
the surgical forceps (fig. 22).
12.2.2 Distal Component — Bare Stent Deployment
If the bare stent cannot be fully deployed from the cap, (fig. 23), advance the
Flexor sheath to the distal edge of the stent graft (figs. 24 and 25).
Stabilize the Flexor sheath and pull back the blue rotation handle (fig. 26).
The bare stent will now be released from the cap but still inside the sheath.
Withdraw the sheath SLoWLY in a rotating movement (fig. 27) until the bare
stent is outside the sheath.
Contrast
Yes
Spiral CT or high performance MDCT
capable of > 40 seconds
Per Instititutional Protocol
>2.5 cc/sec
Power
Test bolus: Smart Prep, C.A.R.E. or equivalent
Subclavian aorta
Profunda femoris origin
<3 mm
2.5 mm throughout - soft algorithm
32 cm
None
MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
888-633-4298 (toll free)
209-668-3333 from outside the US
209-669-2450
www.medicalert.org
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