Disposal; Post-Procedure; Implantable Device Patient Information; Information To Brief The Patient - Boston Scientific WATCHMAN FLX Serie Mode D'emploi

16. If repositioning of the Closure Device is required, recapture the Closure Device per the
following instructions.
A. Advance tip of Access Sheath/Delivery System Assembly up to Closure Device
(do not unsnap).
B. Fix deployment knob position with right hand and gently advance Access
Sheath/ Delivery System Assembly over the Closure Device by positioning the right
thumb against the Delivery System hemostasis valve for stability and push the right
thumb forward. Resistance will be felt as the Closure Device is collapsed into the
Delivery System.
C. Continue to advance Access Sheath/Delivery System Assembly such that the
Closure Device anchors are released from the LAA. The Closure Device may be fully
recaptured into the Access Sheath/Delivery System Assembly as needed prior to
redeployment. After recapture, the WATCHMAN FLX Device may be repositioned using
the guidance found in Step 13.
17. If removal of the Closure Device is required, recapture the Closure Device per the
following instructions.
A. Advance tip of Access Sheath/Delivery System Assembly up to face of Closure Device
(do not unsnap).
B. Fix deployment knob position with right hand and gently advance
Access Sheath / Delivery System Assembly over the Closure Device by positioning
the right thumb against Delivery System hemostasis valve for stability and push the
right thumb forward. Resistance will be felt as the Closure Device is collapsed into the
Delivery System. Continue to advance Assembly until Closure Device is completely
collapsed, recaptured and distal fluoro tip is proximal to the marker band. Tighten
Delivery System hemostasis valve.
C. Unsnap Delivery System from Access Sheath while maintaining Access Sheath
position. Slowly remove Delivery System.
D. Insert pigtail catheter to reposition Access Sheath in LAA if necessary.
E. Repeat Steps 8 - 15 with new Delivery System.
18. If the Closure Device meets release criteria, release WATCHMAN FLX Device.
Warning: Do not release the WATCHMAN FLX Device from the core wire if the
Closure Device does not meet all release criteria (Step 15).
A. Confirm proper Closure Device release criteria: Position, Anchor, Size, and Seal
(PASS criteria).
B. Advance Access Sheath/Delivery System Assembly to face of Closure Device.
C. Rotate deployment knob counterclockwise 3 - 5 full turns.
D. Confirm core wire is disconnected.
19. Remove Access Sheath and Delivery System based on parameters for hemostasis.
20. Use standard of care for post-procedure bleeding at access site.

Disposal

To minimize the risk of infection or microbial hazards after use, dispose of device and
packaging as follows:
After use, device may contain biohazardous substances. The device and packaging should
be treated and disposed of as biohazardous waste or have them treated and disposed of in
accordance with any applicable hospital, administrative, and/or local government regulations.
Use of a biohazardous container with biological hazard symbol is recommended. Untreated
biohazardous waste should not be disposed of in the municipal waste system.

Post-Procedure

1. At approximately 6 weeks (45 days) after implant, use preferred imaging modality to
assess WATCHMAN FLX Device.
• Confirm absence of intra-cardiac thrombus.
• Through multiple imaging views, ensure all lobes of the LAA are distal to
the WATCHMAN FLX Device and sealed (i.e., no leak > 5 mm).
2. The rationale for choosing between option A or option B below should be based on
physician assessment of individual patient characteristics, such as bleeding risk, stroke
risk, and patient preference.
A. Post-implant drug regimen for patients prescribed Dual Anti-Platelet Therapy (DAPT) only:
• Patient should begin clopidogrel daily and aspirin daily for at least 3 months
post-implant.
• Clinical study data establishing safety and effectiveness are based on demonstration
of peri-device flow ≤ 5 mm as a measure of adequacy of LAA seal. If adequate seal
is not demonstrated, decision to discontinue clopidogrel is at physician discretion.
Patient should remain on aspirin at least 12 months after implantation.
• If thrombus is observed on the device, use of anticoagulation is at physician discretion.
B. Post-implant drug regimen for patients prescribed short-term Oral Anticoagulant
(OAC) therapy:
• Patients should begin aspirin and either Non-Vitamin K Antagonist Oral
Anticoagulants (NOACs) or warfarin (INR 2.0 - 3.0) for at least 45 days post-implant.
38 MB Drawing 50573138
• Clinical study data establishing safety and effectiveness are based on demonstration
of peri-device flow ≤ 5 mm as a measure of adequacy of LAA seal. If adequate seal is
not demonstrated, decision to discontinue OAC is at physician discretion.
• If thrombus is observed on the device, use of anticoagulation is at physician discretion.
• After cessation of OAC, the patient should remain on aspirin and begin clopidogrel
until at least 3 months have elapsed after implantation. Patient should remain on
aspirin for at least 12 months after implantation.
• If a patient remains on OAC and aspirin for at least 3 months after implantation and
then ceases use of OAC, the patient should not require clopidogrel. After cessation
of OAC, the patient should remain on aspirin at least 12 months after implantation.
Note: Clopidogrel may be substituted with another P2Y
the medication for other indications (e.g., acute coronary syndromes treated with
drug-eluting stents) or if the subject cannot take clopidogrel. See drug manufacturer
recommendations for use.
3. Prescribe appropriate endocarditis prophylaxis for 6 months following Closure Device
implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at
physician discretion.
Any serious incident that occurs in relation to this device should be reported to the
manufacturer and relevant local regulatory authority.

Implantable Device Patient Information

Advise the patient that additional information may be available to them on the
Boston Scientific website (www.bostonscientific.com/patientlabeling).

INFORMATION TO BRIEF THE PATIENT

The following sections/clauses in the IFU contain information that may be useful for briefing
the patient prior to use of this device:
• Clinical benefit
• Potential adverse events
• Warnings/Precautions (statements with potential relevance to the patient are in italics)
The following may be useful for briefing the patient prior to use of this device:
• The WATCHMAN Device is for patients with non-valvular atrial fibrillation
• MR Compatible (1.5 T and 3 T) immediately after implant
• Expected TEE follow up at 45 days and 12 months
• Expected change in drug regimen at 45 days and/or 6 months
• Device is contra-indicated for patients with a nickel allergy
• Device is a permanent implantable device and has been tested for structural integrity
(fracture resistance) for a minimum of 10 years; however, the materials of the device are
nonbiodegradable and are intended to last for the lifetime of the patient.
Provide the patient with the completed implant card and advise the patient to carry the card
with them at all times. Instruct the patient to present the implant card to their Healthcare
professionals (doctors, dentist, technicians) so they can take the necessary precautions.

WARRANTY

For device warranty information, visit (www.bostonscientific.com/warranty).
WATCHMAN and WATCHMAN FLX are trademarks of Boston Scientific Corporation or its affiliates.
All other trademarks are the property of their respective owners.
Magnetom Trio and syngo are trademarks of Siemens Aktiengesellschaft Corp.
7
12 inhibitor if the subject requires
Black (K) ∆E ≤5.0