Edwards PASCAL Gebrauchsanweisung Seite 4

• Neurological symptoms, including dyskinesia, without diagnosis of
TIA or stroke
• Non-neurological thromboembolic events
• Pain
• Papillary muscle damage
• Paralysis
• PASCAL system component(s) embolization
• Peripheral ischemia
• Pleural effusion
• Pulmonary edema
• Pulmonary embolism
• Reaction to anti-platelet or anticoagulation agents
• Renal failure
• Renal insufficiency
• Respiratory compromise, respiratory failure, atelectasis, pneumonia - may
require prolonged ventilation
• Retroperitoneal bleed
• Septal damage or perforation
• Septicemia, sepsis
• Skin burn, injury or tissue changes due to exposure to ionizing radiation
• Single leaflet device attachment (SLDA)
• Stroke
• Syncope
• Transient ischemic attack (TIA)
• Urinary tract infection and/or bleeding
• Valve injury
• Valve stenosis
• Valvular regurgitation
• Vascular injury or trauma, including dissection or occlusion
• Vessel spasm
• Ventricular wall damage or perforation
• Wound dehiscence, delayed or incomplete healing
• Worsening of heart failure
• Worsening regurgitation / valvular insufficiency
6.0 How Supplied
6.1 Packaging
The Guide Sheath, Implant System, and Stabilizer are individually packaged
and ethylene oxide sterilized . The Table is packaged and provided non-sterile .
6.2 Storage
The PASCAL system should be stored in a cool, dry place .
7.0 Directions for Use
7.1 Physician Training
The implanting physician shall be experienced in transcatheter techniques
and trained on the PASCAL system and implant procedure . The final decision
for PASCAL device implantation should be made by physicians specializing in
treatment of mitral and/or tricuspid regurgitation in specialized centers who
can determine a reasonable chance of significant clinical improvement should
be expected based on stage of disease and comorbidity .
7.2 Equipment and Materials
• Standard cardiac catheterization lab equipment
• Fluoroscopy system
• Transesophageal echocardiography (TEE) capabilities (2D and 3D)
• Pigtail catheter for contrast injection (with compatible sheath)
• Venous puncture kit
• Transseptal needle, sheath, and guidewire
• Exchange length 0 . 0 35 inch (0 . 8 9 mm) guidewire
• Basins
• 50-60 cc syringes with Luer fitting
• Heparinized saline
• Hemostat
• Surgical towels (e . g . size 43 x 69 cm)
• Optional: Step-up dilators
• Optional: Continuous physiological saline drip (Rolling IV pole, IV tubing
with thumbwheel occluders, 1-liter bags of heparinized sterile
saline solution)
• Optional: Pressure monitoring device
7.3 Device Preparation
7.3.1 Table
Step Procedure
1 Remove the Table(s) from packaging and inspect for damage .
2 Assemble the Table(s) as seen in Figure 7 .
7.3.2 Stabilizer
Step Procedure
1 Remove the Stabilizer from packaging and inspect for damage .
2 Assemble the Stabilizer as seen in Figure 6 .
7.3.3 Guide Sheath
Step Procedure
1 Remove the Guide Sheath, Loader, and Introducer from
packaging and inspect for gross damage .
2 While keeping distal tip raised, flush and de-air Guide Sheath
with heparinized saline .
3 While keeping the distal tip raised, insert Introducer into Guide
Sheath . Flush the Introducer and wipe Guide Sheath with
heparinized saline prior to use .
7.3.4 Implant System
Step Procedure
1 Remove Implant System and Loader from packaging and
inspect for gross damage . Verify both Slider Stopcocks are in
open position .
WARNING: If Slider Stopcocks are not in open position,
use of the device may result in infection.
2 Advance the Actuation Knob (rotate the Actuation Knob
counterclockwise or press the Actuation Button to push forward
the Actuation Knob) until it is flush against the Clasp
Positioning Tool .
3 Remove the Slider Pin and remove suture slack . Lock Slider
Stopcocks and secure Slider Pin . Remove Clasp Positioning Tool .
4 Fully retract and advance Sliders to confirm proper Clasp motion
and close the Implant (rotate the Actuation Knob clockwise or
press the Actuation Button to retract the Actuation Knob) .
5 Advance the Steerable Catheter . Ensure Sliders are fully
retracted and Actuation Knob fully retracted . Orient Implant
Catheter Handle vertically so the Release Knob is against
the table .
6 Flush heparinized saline through the Implant Catheter .
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