Magnetic Resonance Imaging; 3.0 Tesla Temperature Information; Image Artifact Information; Precautions - Boston Scientific WATCHMAN FLX Serie Mode D'emploi

MAGNETIC RESONANCE IMAGING

Non-clinical testing has demonstrated the WATCHMAN FLX Device is MR Conditional.
A patient with the Closure Device can be scanned safely, immediately after placement of this
implant, under the following conditions:
• Static magnetic fields of 3.0 Tesla or 1.5 Tesla
• Spatial gradient field of 2500 Gauss/cm or less
• Spatial gradient field product of 37 T /m or less
²
• 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 FLX Device should not migrate in this MRI environment. MR imaging
within these conditions may be performed immediately following the implantation of the
Closure Device. This Closure Device has not been evaluated to determine if it is MR Conditional
beyond these parameters.

3.0 Tesla Temperature Information

Non-clinical testing of RF-induced heating in the WATCHMAN FLX Device was performed
at 128 MHz in a 3.0 Tesla whole body coil MR scanner (Magnetom Trio, Software Release
Numaris/4 syngo MR B17, Siemens Medical Solutions, Erlangen, Germany) and produced
a temperature rise of < 2.0 °C at an MR extrapolated SAR of 2.0 W/kg for 15 minutes of
continuous MR scanning.
These calculations do not take into consideration the cooling effects of blood flow.
1.5 Tesla Temperature Information
Non-clinical testing of RF-induced heating in the WATCHMAN FLX Device was performed at
64 MHz in a 1.5 Tesla whole body coil MR scanner (Intera, Software Release 12.6.1.4 2012-05-22,
Philips Medical Systems, Best, The Netherlands) and produced a temperature rise of < 3.0 °C
at an MR extrapolated SAR of 2.0 W/kg for 15 minutes of continuous MR scanning.
These calculations do not take into consideration the cooling effects of blood flow.

Image Artifact Information

In non-clinical testing, the image artifact caused by the device extends less than 4.8 mm
from the WATCHMAN FLX Device when imaged with a spin echo pulse sequence and a
3.0 Tesla MRI system. The image artifact caused by the device extends less than 8.4 mm from
the WATCHMAN FLX Device when imaged with a gradient echo pulse sequence and a 3.0 Tesla
MRI system. MR image quality may be compromised if the area of interest is relatively close to
the WATCHMAN FLX Device. Optimization of MR imaging parameters is recommended.

PRECAUTIONS

• The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying,
recapturing, and repositioning the Closure Device.
• Use caution when introducing any WATCHMAN Access System to prevent damage to
cardiac structures.
• Use caution when introducing Delivery System to prevent damage to cardiac structures.
• Use caution when manipulating the Delivery System. Excessive counterclockwise rotation
of the deployment knob or Delivery System hub independent from the rest of the
Delivery System can cause premature implant detachment.
• To prevent damage to the Delivery Catheter or Closure Device, do not allow the
WATCHMAN FLX Device to protrude beyond the Delivery Catheter when inserting the
Delivery System into an Access Sheath.
• If using a power injector, the maximum pressure should not exceed 690 kPa (100 psi).
• There are many sources of thromboembolism in patients with non-valvular
atrial fibrillation. The WATCHMAN FLX Device is designed to reduce the risk of
thromboembolism originating from the LAA. Although the LAA is a common source
of stroke in this setting, it is not the sole source. Therefore, the WATCHMAN FLX Device
would not be expected to reduce the risk of ischemic stroke unrelated to cardioembolism
from the LAA and other potential risk factors for stroke should be considered
(e.g., cerebrovascular disease, hypercoagulable states).

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a
left atrial appendage closure device or implantation procedure include but are not limited to:
• Air embolism
• Airway trauma
• Allergic reaction to contrast media, anesthetic, WATCHMAN Implant material, or medications
• Altered mental status
• Anemia requiring transfusion
• Anesthesia risks
• Angina
• Anoxic encephalopathy
• Arrhythmias
Black (K) ∆E ≤5.0
• Atrial septal defect
• Bruising, hematoma, or seroma near the catheter insertion site
• Cardiac perforation
• Chest pain/discomfort
• Confusion post-procedure
• Congestive heart failure
• Contrast-related nephropathy
• Cranial bleed
• Death
• Decreased hemoglobin
• Deep vein thrombosis
• Device embolism
• Device fracture
• Device thrombosis
• Edema
• Embolism
• Excessive bleeding
• Fever
• Fistula
• Groin pain
• Groin puncture bleed
• Hematuria
• Hemoptysis
• Hypotension
• Hypoxia
• Improper wound healing
• Inability to reposition, recapture, or retrieve the device
• Infection/pneumonia
• Interatrial septum thrombus
• Intratracheal bleeding
• Major bleeding requiring transfusion
• Misplacement of the device/improper seal of the appendage/movement of device from
appendage wall
• Myocardial erosion
• Myocardial infarction
• Nausea
• Oral bleeding
• Pericardial effusion/tamponade
• Pleural effusion
• Prolonged bleeding from a laceration
• Pseudoaneurysm
• Pulmonary edema
• Radiation injury
• Renal failure
• Respiratory insufficiency/failure
• Stroke - Hemorrhagic
• Stroke - Ischemic
• Surgical removal of the device
• TEE complications (e.g., throat pain, bleeding, esophageal trauma)
• Thrombocytopenia
• Thrombosis
• Transient ischemic attack (TIA)
• Valvular or vascular damage
• Vasovagal reactions
There may be other potential adverse events that are unforeseen at this time.

HOW SUPPLIED

• The WATCHMAN FLX Device is pre-loaded in the Delivery System.
• The WATCHMAN FLX Device with Delivery System is supplied STERILE using an
ethylene oxide (EO) process.
• WATCHMAN Access Systems are packaged separately.
4
MB Drawing 50573138 M