Boston Scientific WATCHMAN 12F Instrucciones De Uso página 4

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 resulting induced voltages.
Image artifact Information
MR image quality may be compromised if the area of interest is relatively close to the
WATCHMAN device. Optimization of MR imaging parameters is recommended.
precaUtIons
None known.
aDverse events
Adverse events reported during the clinical study were adjudicated by the Clinical
Events Committee and are as follows:
• Pericardial Effusion
• Excessive Bleeding
• Gastrointestinal Bleeding
• Stroke - Ischemic
• Death
• Device Thrombus
• Hypotension
• Major Bleed Requiring Transfusion
• Bruising - Hematoma
• Inability to Move or Retrieve Device
• Anemia Requiring Transfusion
• Allergic Reaction to Contrast Media/Meds
• Infection/Pneumonia
• Device Embolization
• Pseudoaneurysm
• TEE Complications (throat pain, bleeding)
• Systemic Embolism
• Pleural Effusion
• AV Fistula
• Transient Ischemic Attack (TIA)
• Arrhythmias
• Thrombus at Septal Puncture
• Post Procedure Anesthesia Effects
• Thrombosis
• Groin Puncture Bleed
• Pulmonary Edema
• Vasovagal Reactions
• Cranial Bleed
• Air Embolism
• Stroke – Hemorrhagic
Some additional events that may be expected in catheterization procedures include:
• Pneumothorax
• Pulmonary Vein Obstruction
• Valvular or vascular damage
How sUpplIeD
• The WATCHMAN LAA Closure Device is pre-loaded in the Delivery System.
• The WATCHMAN Access System is packaged separately.
• The WATCHMAN LAA Closure products are supplied STERILE using an ethylene
oxide (EO) process.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
note: Contents of inner package are STERILE.
HanDlInG anD storaGe
Store in a cool, dry, dark place.
operatIonal InstrUctIons
pre-procedural Instructions
A baseline TEE should be performed to verify that a WATCHMAN LAA Closure Device
may be implanted.
Black (K) ∆E ≤5.0
1. Assess the following through multiple imaging planes (0° - 135° sweep):
• LAA size /shape, number of lobes in LAA, and location of lobes to ostium.
• Confirm the absence of thrombus (use Color Doppler and echo contrast as
necessary).
2. Record LAA ostium and LAA length measurements (0° - 135° sweep). Measure the
LAA ostium at approximately these angles.
• at 0° measure from coronary artery marker to a point 2 cm from tip of the
"limbus"
• at 45° measure from top of the mitral valve annulus to a point 2 cm from tip of the
"limbus"
• at 90° measure from top of the mitral valve annulus to a point 2 cm from tip of the
"limbus"
• at 135° measure from top of the mitral valve annulus to a point 2 cm from tip of
the "limbus"
Measured maximum LAA ostium width must be ≥17mm or ≤31mm to accommodate
available device sizes.
note: The maximum LAA ostium and LAA length measurements determine device size
selection.
proceDUral InstrUctIons
equipment needed for Implantation procedure
• Venous Introducer (optional)
• Standard transseptal access system
• 0.035" guidewire (exchange length extra support)
• 6Fr Pigtail Catheter
Core Wire
Hemostasis Valve
Distal Marker Band
figure 1. watcHMan Delivery system (Delivery catheter and Device)
• Access Sheath
• Dilator
figure 2. watcHMan access system (access sheath/Dilator)
Implantation procedure
warnInG: The use of echocardiographic imaging is required (TEE is recommended as
an aid in placing the WATCHMAN Device).
note: Patients should be fully heparinized throughout the procedure with a
recommended minimum active clotting time (ACT) of 200-300 seconds after
transseptal puncture.
1. Use standard practice to puncture vessel and insert 0.035" guidewire and vessel
dilator. Use a standard transseptal access system to cross inter-atrial septum.
4
Stopcock
Anchors
Deployment Knob
Threaded
Insert
PET Fabric
Distal Tines