AtriCure AtriClip® Flex-V® LAA Exclusion System with Preloaded V Clip™

Indications for Use

The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage (LAA), performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization requires the surgeon to see the heart directly, with or without assistance from a camera, endoscope, or other appropriate viewing technologies.

Contraindications

1. Do not use this device as a contraceptive tubal occlusion device.
2. Do not use this device if there is evidence of systemic infection, bacterial endocarditis, or in the presence of an infected operating field.

System Description

The AtriClip Flex-V LAA Exclusion System is a delivery and deployment device preloaded with a V Clip for the exclusion of the LAA. Preclinical studies suggest complete exclusion also results in acute and chronic electrical isolation of the LAA. A human clinical study demonstrated acute electrical isolation; chronic electrical isolation has not been evaluated in human studies.

The V Clip is a permanent implant, intended for the patient's lifetime. It is composed of Grade 5 Titanium and covered in a knit-braided Polyethylene Terephthalate fabric containing titanium dioxide. The system is not made with natural rubber latex and does not contain phthalates. It is "MR Conditional" per ASTM F2503-20.

Materials Information for Implanted V Clip (35mm to 50mm)

Environmental Specifications

Storage

• Temperature: -29°C/-20°F to 60°C/140°F
• Relative Humidity: 15% to 85%
• Atmospheric Pressure: N/A

Transit

• Temperature: -29°C/-20°F to 60°C/140°F
• Relative Humidity: 30% to 85%
• Atmospheric Pressure: N/A

Package Contents

1. One (1) AtriClip Flex-V LAA Exclusion System with Preloaded V Clip
2. One (1) Implant Card and (1) Implant Card Leaflet

The system is supplied STERILE and NON-PYROGENIC in an unopened, undamaged package. For single use only. Do not re-sterilize. Do not re-use.

System Accessories

Other devices may be used in conjunction with the AtriClip Flex-V LAA Exclusion System, including the Selection Guide (CGG100), which is packaged separately.

Nomenclature (See Figure 1)

• [1] V Clip
• [2] Clip Opening Jaws
• [3] End Effector
• [4] Shaft¹ (The entire length of the Shaft is malleable and intended for adjustments up to 45 degrees in any direction.)
• [5] Shaft Rotation Knob
• [6] Deployment Trigger
• [7] Activation Lever
• [8] Handle

Figure 1: Diagram showing the components of the AtriClip Flex-V LAA Exclusion System.

Figure 2: Diagram illustrating clip size selection based on LAA size.

Figure 3: Diagram showing shaft bending for anatomical access.

Figure 4: Diagram illustrating shaft rotation.

Figure 5: Diagram showing the clip opening mechanism.

Figure 6: Diagram showing clip positioning at the base of the LAA.

Figure 7: Diagram illustrating deployment trigger activation.

Figure 8: Diagram showing removal of the device after deployment.

Warnings

Read all instructions carefully before use. Use the device only as intended and limit use to properly trained and qualified medical personnel. Improper use may lead to device malfunction, failure to provide intended therapy, or serious injury.

• Do not use on tissue that cannot tolerate conventional suture materials or closure techniques, as this may cause tissue trauma, dehiscence, tearing, displacement, or lack of hemostasis.
• The safety and effectiveness for atrial rhythm control management, alone or with ablative treatment, has not been established.
• AtriClip placement allowing blood flow may not result in complete exclusion or electrical isolation.
• DO NOT RESTERILIZE. The system is sterile and intended for single use only. Re-sterilization may cause loss of function or injury.
• Evaluate for thrombus in the LAA. Do not place the Clip on an LAA with evidence of thrombus, as this may result in serious patient injury.
• This device contains small amounts of Nickel (CAS# 7440-02-0) and Cobalt (CAS# 7440-48-4). Do not use if the patient has sensitivity to Nickel or Cobalt.

Complications

Potential complications associated with the use of the AtriClip Flex-V LAA Exclusion System and procedure include, but are not limited to:

• Air embolism
• Allergic reaction (anesthesia, anticoagulant, implant material)
• Anaphylactic shock
• Anesthesia risks
• Aneurysm
• Angina
• Arrhythmia needing medical treatment (new onset)
• Arterial or venous dissection and/or perforation
• Arterial rupture
• Arterial spasm
• Arteriovenous fistula
• Atelectasis (major lung collapse)
• Atrial rupture
• Atrio-esophageal fistula
• AV block requiring permanent pacemaker (new onset)
• Bleeding requiring intervention
• Blood vessel damage
• Cardiac perforation
• Cardiac tamponade
• Cardiac valve injury
• Cerebrovascular accident (CVA)/Transient Ischemic Attack (TIA)/stroke
• Chest pain/discomfort
• Compression of coronary artery
• Conduction disturbances
• Congestive heart failure (new onset or exacerbation)
• Coronary artery injury
• Death
• Device breakage/inability to remove
• Device-related death
• Diaphragmatic paralysis
• Drug reaction
• Emergency during procedure requiring a change in planned access
• Empyema
• Endocarditis (bacterial)
• Esophageal injury
• Esophageal rupture
• Extension of cardiopulmonary/extracorporeal bypass
• Fever
• Gastric motility disorders
• Gastro-intestinal bleed
• Hematoma
• Hematuria
• Hemothorax
• Hypertension
• Hypotension
• Iatrogenic atrial flutter
• Iatrogenic lung injury
• Ischemia
• Kinking of coronary artery
• LAA dehiscence
• LAA tears
• Left atrial embolism
• Myocardial infarction (MI)
• Nerve injury
• Pain/discomfort
• Pericardial effusion
• Pericarditis
• Permanent pacemaker
• Persistent chest pain
• Phrenic nerve paralysis
• Pleural effusion
• Pneumonia
• Pneumothorax
• Postoperative embolic complications
• Pseudoaneurysm
• Pulmonary edema
• Pulmonary embolism
• Renal insufficiency or failure
• Respiratory distress or failure
• Sepsis
• Stenosis of left circumflex artery
• Sterility-related infection
• Superficial wound infection
• Surgical site infection
• Systemic adverse reaction due to device corrosion
• Thrombus and/or thromboembolism
• Tissue injury
• Tissue perforation
• Tracheal esophageal trauma
• Vascular access complications

Clip Selection

Surgeon judgment, with the assistance of the Guide, should determine the correct clip size. This IFU is designed to assist in using the product, not as a reference to surgical techniques.

Warning: Carefully consider any presurgical treatment the patient may have undergone. Preoperative radiotherapy may alter tissue thickness, potentially exceeding the indicated range for the selected clip size. Incorrect sizing may result in tissue trauma, dehiscence, tearing, displacement, lack of hemostasis, or incomplete exclusion.

1. Using the Guide, determine the correct selection of the V Clip. Clip sizes are located on the device package.

Warning: Do not use on an LAA less than 29 mm width and 1 mm wall thickness. Do not use on an LAA greater than 50 mm when tissue is uncompressed. Failure to adhere may result in tissue trauma, dehiscence, tearing, displacement, lack of hemostasis, or incomplete exclusion.

Procedure Steps

1. Using sterile technique, remove the AtriClip Flex-V LAA Exclusion System from its packaging.

   Warning: If the sterile package is damaged or the sterile barrier is breached, discard the device to avoid patient infection.

   Caution: Do not drop the device. If dropped, do not use; replace with a new device.

2. Using the Activation Lever on the Handle, gently open and close the Clip to assure proper function.
3. Shaft Bending:

   Caution: Do not grasp the End Effector to bend the Shaft; this may damage the device. Apply bend by concentrating force under both thumbs. Excessive bending or kinking may affect performance. Do not twist the End Effector.

   The AtriClip Flex-V contains a malleable Shaft that may be reshaped to aid in accessing the LAA. Apply gentle pressure to shape the Shaft as required for anatomical variations (See Figure 3).

4. Shaft Rotation:

   Caution: Do not attempt to rotate the End Effector without pulling it out of the locked position. Force applied while locked may damage the device.

   By pulling the Shaft Rotation Knob forward and twisting it, the End Effector can be manually rotated side-to-side. The Clip and End Effector can rotate 90° left or right in 45° increments (See Figure 4).

   To lock the End Effector, release forward pressure on the Shaft Rotation Knob and ensure it is seated.

5. Clip Positioning:

   Warning: Position and deploy the Clip with direct visualization of all tissues being accessed. Poor visualization may result in suboptimal placement and damage to surrounding structures.

   With the Clip in the closed position, maneuver the system into the targeted dissection plane.

   Gently open the Clip by squeezing the Activation Lever (See Figure 5). Maintain pressure on the Activation Lever to hold the Clip open; there is no automatic locking function.

   Gently position the Clip at the base of the LAA (See Figure 6). Ensure clear visualization of all tissues.

   While the Clip is affixed to the Deployment Device, ensure no surrounding structures interfere with or are damaged by the Clip, and that placement is correct.

   Slowly release the Activation Lever to allow the Clip to close.

   If the Clip is not placed correctly, gently open and reposition as needed.

6. Deployment:

   Warning: Carefully evaluate Clip position, tissue thickness, and width prior to deployment. Refer to the Guide for appropriate clip sizing. Incorrect sizing or deployment may result in tissue trauma, dehiscence, tearing, displacement, or lack of hemostasis.

   Unless medically necessary, do not attempt to reposition or remove the Clip after deployment, as this may cause tissue damage or tearing.

   Deploy the Clip by pulling the Deployment Trigger at the nose of the Handle (See Figure 7). Only pull the trigger when the Clip is properly positioned over the LAA. Pulling the trigger permanently releases the Clip from the applier.

   An audible "click" will be heard upon activation.

   Caution: Minimize manipulation of the LAA and Clip after deployment.

   Carefully remove the End Effector from the LAA, leaving the Clip and attachment suture behind (See Figure 8).

   Note: After pulling the Deployment Trigger, the system cannot be used to reposition or remove the Clip.

Disposal Information

After use, this device should be treated as medical waste and disposed of following hospital protocol.

Serious Incident Reporting

Any serious incident related to this device should be reported to AtriCure.

Return of Used Product

If the product must be returned to AtriCure, Inc., a return goods authorization (RGA) number is required prior to shipping. If the product has been in contact with blood or body fluids, it must be cleaned and disinfected before packing. Ship in original or equivalent carton, properly labeled with RGA number and biohazardous indication. Instructions for cleaning, materials, shipping, and labeling are available from AtriCure, Inc.

Disclaimer Statements

Users assume responsibility for approving the product's acceptable condition before use and for ensuring it is used only as described in these instructions, including not re-using the product. AtriCure, Inc. is not responsible for incidental, special, or consequential loss, damage, or expense resulting from deliberate misuse or re-use of this product.

Handling Information: V Clip

MRI Safety Information:

MR Conditional

Non-clinical testing demonstrated the V Clip is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:

• Static magnetic field of 1.5-Tesla and 3-Tesla, only.
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40-T/m) or less.
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (per pulse sequence) in the First Level Controlled Operating Mode.
• Scan conditions are expected to produce a maximum temperature rise of 3.1°C (5.58°F) after 15 minutes of continuous scanning.

Artifact Information:

In non-clinical testing, the image artifact caused by the V Clip extends approximately 20 mm (0.79 in) from the V Clip when imaged using a gradient echo pulse sequence and a 3 Tesla MR System.

Symbols Glossary

Refer to the outer package label for applicable symbols.

• ? Single sterile barrier system with protective packaging outside
• ? Single sterile barrier system with protective packaging inside
• ? Manufacturer
• ⚠️ Caution
• ? [Phthalate-Free]
• ☣️ Hazardous Substances
• ❌ [Damaged Package Warning]
• ? [Non-Pyrogenic]
• ☢️ [Sterilized by Irradiation]
• ℹ️ Consult Instructions For Use
• ?? [Do Not Re-use]
• ?? [Latex-Free]
• #️⃣ Model Number
• #️⃣ Catalogue Number
• ? Unique Device Identifier
• #️⃣ Lot Number
• ⚠️ [Physician Order Only]
• ?? [Country of Manufacture]
• ? Use-by date
• ⚕️ [MR Conditional]
• ⚕️ [Medical Device]
• ? Keep dry
• ?️ Transit Temperature limit
• ? Transit Humidity limit