Boston Scientific WATCHMAN 12F Instrucciones De Uso página 3

WATCHMAN
1 2 F
Left Atrial Appendage Closure Device
with Delivery System
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
warnInG
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative
and/or local government policy.
DevIce DescrIptIon
The WATCHMAN LEFT ATRIAL APPENDAGE (LAA) Closure Technology consists of the
Access System (Access Sheath and Dilator) and Delivery System (Delivery Catheter
and LAA Closure Device). The Access System and Delivery System permit Device
placement in the LAA via femoral venous access and inter-atrial septum crossing into
the left atrium. The WATCHMAN Device is a self-expanding nitinol structure with a
porous membrane on the proximal face. The Device is constrained within the Delivery
System until deployment in the LAA. The Device is available in 5 sizes from 21 to 33 mm.
Device selection is determined by LAA measurements using Fluoroscopy (Fluoro) and
Transesophageal Echocardiography (TEE).
The WATCHMAN LAA Closure Device is designed to be permanently implanted at or
slightly distal to the ostium (opening) of the LAA to trap potential emboli before they exit
the LAA. The placement procedure can be done under local or general anesthesia in a
catheterization laboratory setting.
contents
Quantity Description
1 WATCHMAN Left Atrial Appendage Closure Device with Delivery System
IntenDeD Use/ InDIcatIons for Use
The WATCHMAN LAA Closure Technology is intended to prevent thrombus embolization
from the left atrial appendage and reduce the risk of life-threatening bleeding events in
patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy
or who have a contraindication to anticoagulation therapy.
contraInDIcatIons
Do not use the WATCHMAN LAA Closure Device if:
• Intracardiac thrombus is visualized by echocardiographic imaging.
note: If thrombus is identified in the LAA, dissolve with anticoagulation therapy
before attempting to implant the WATCHMAN Device.
• An atrial septal repair or closure device is present.
• The LAA anatomy will not accommodate a Device. See Table 1
• Any of the customary contraindications for other percutaneous catheterization
interventions eg. patient size (i.e. too small for TEE probe, catheter size, etc.) or
condition (i.e. active infection, bleeding disorder, untreated ulcer, etc.) are present.
warnInGs
Implantation of the WATCHMAN LAA Closure Device should only be performed by
physicians trained in percutaneous and transseptal procedures who have completed
the WATCHMAN training program.
• the laa is a thin walled structure. Use caution when accessing the laa and
deploying the Device.
• The WATCHMAN Access and Delivery Systems are sterile and intended for single
use only. Do not reuse or resterilize. Reuse could result in product damage and/
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3
or breakage that could lead to clinical complications, possibly requiring prolonged
hospitalization. Resterilization could result in product contamination resulting in
infection (e.g. endocarditis/sepsis/local infection), possibly requiring antibiotics or
prolonged hospitalization.
• Careful consideration should be given to use of the Device in pregnant and/or
breastfeeding women due to the risk of significant exposure to x-rays and the use
of strong anticoagulation medication.
• The WATCHMAN device has not been studied in patients under the age of 18.
• Device selection should be based on accurate LAA measurements obtained using
Fluoro and TEE in multiple angles (e.g. 0º, 45º, 90º, 135º).
• Aspirin should be started one day prior to scheduled procedure and continued daily.
• Patients should be fully heparinized throughout the procedure with an active
clotting time (ACT) of 200 - 300 seconds after transseptal puncture.
• Fluoro and TEE should be used when implanting the Device.
• Do not release (unscrew) the Device unless release criteria (step 14) are satisfied.
• Potential for Device embolization exists with cardioversion < 30 days following
Device implantation, verify Device position post cardioversion.
• Post- procedure warfarin therapy is required in ALL patients receiving a Device
who are eligible for warfarin therapy or other equivalent oral anticoagulant per
institution's protocol. Patients should remain on 81-100 mg of aspirin and warfarin
for a minimum of 45 days post implant (INR 2.0-3.0). At 45 days post implant perform
Device assessment with TEE. Cessation of warfarin is at physician discretion.
Patients ceasing warfarin should begin clopidogrel 75mg daily and increase aspirin
dosage to 300-325mg daily for 6 months post-implant and remain on aspirin 300-
325mg indefinitely. For patients contraindicated to anticoagulation therapy, begin
clopidogrel 75mg daily and aspirin 300-325mg daily for 6 months post-implant and
remain on aspirin 300-325mg indefinitely. A visual assessment with TEE should be
performed 45 days post implant to assess the device.
• Administer appropriate endocarditis prophylaxis for 6 months following device
implantation. The decision to continue endocarditis prophylaxis beyond 6 months is
at physician discretion.
MaGnetIc resonance IMaGInG
The WATCHMAN LAA Closure Device was determined to be MR Conditional per:
(International, Designation: F2503-05. Standard Practice for Marking Medical Devices
for Safety in the MR Environment. ASTM International, 100 Barr Harbor Drive, PO Box
C700, West Conshohocken, Pennsylvania, 19428, 2005).
Non-clinical testing has demonstrated the WATCHMAN device is MR Conditional. A
patient with the Device can be scanned safely under the following conditions:
• Static magnetic fields of 3 Tesla or 1.5 Tesla
• Spatial gradient field of 2500 Gauss/cm or less
• The maximum whole body averaged specific absorption rate (SAR) shall be limited
to 2.0 W/kg (normal operating mode only) for 15 minutes of continuous application
of RF energy during a scan
• Normal operating mode of the MRI scanner
The WATCHMAN LAA Closure Device should not migrate in this MRI environment.
MR imaging within these conditions may be performed immediately following the
implantation of the device. This device has not been evaluated to determine if it is MR
Conditional beyond these parameters.
3.0 tesla temperature Information
In non-clinical testing, the WATCHMAN LAA Closure Device produced a temperature
rise of < 1.1°C at a maximum MR system-reported SAR of 2.0 W/kg as measured by
calorimetry for 15 minutes of continuous MR scanning in a 3 Tesla MR system (Excite,
Software G3.0-052B, GE Healthcare, Milwaukee, WI).
The actual in vivo temperature rise is expected to be less than these values as the
calculations did not include the cooling effects due to blood perfusion in the tissue
outside the WATCHMAN device. In vivo, local SAR depends on MR field strength and
may be different than the estimated whole body averaged SAR, due to body composition,
device position within the imaging field, and scanner used, thereby affecting the actual
temperature rise. No tests have been performed on possible nerve or other tissue
stimulation activated by strong gradient magnetic fields and the resulting induced
voltages.
1.5 tesla temperature Information
Non-clinical testing of RF-induced heating in the WATCHMAN LAA Closure Device
was performed at 64 MHz in a 1.5 Tesla whole body coil MR scanner (Intera, Software
Release 10.6.2.4, 2006-03-10, Philips Medical Systems, Andover, MA) and produced a
temperature rise of < 1.5°C at an MR extrapolated SAR of 2.0 W/kg for 15 minutes of
continuous MR scanning.
The actual in vivo temperature rise is expected to be less than these values as the
calculations did not include the cooling effects due to blood perfusion in the tissue
Black (K) ∆E ≤5.0