Edwards PASCAL Manual Del Usuario página 2

3.2 Device Handling
• The devices are designed, intended, and distributed for single use only. There are no data to
support the sterility, non-pyrogenicity, and functionality of the devices after reprocessing.
• Devices should be handled using standard sterile technique to prevent infection.
• Do not expose any of the devices to any solutions, chemicals, etc., except for the sterile
physiological and/or heparinized saline solution. Irreparable damage to the device, which
may not be apparent under visual inspection, may result.
• Do not use any of the devices in the presence of combustible or flammable gases,
anesthetics, or cleaners/disinfectants.
• Do not use the devices if the expiration date has elapsed.
• Do not use if the packaging seal is broken or if the packaging is damaged for sterile devices.
• Do not use if any of the devices were dropped, damaged or mishandled in any way.
• Standard flushing and de-airing technique should be used during preparation and
throughout procedure to prevent air embolism.
3.3 Clinical Warnings
• As with any implanted medical device, there is a potential for an adverse immunological
response.
• Serious adverse events, sometimes leading to surgical intervention and/or death, may be
associated with the use of this system ("Potential Adverse Events"). A full explanation of the
benefits and risks should be given to each prospective patient before use.
• Careful and continuous medical follow-up is advised so that implant-related complications
can be diagnosed and properly managed.
• Anticoagulation therapy must be determined by the physician per institutional guidelines.
4.0 Precautions
4.1 Precautions Prior to Use
• Patient selection should be performed by a multi-disciplinary heart team specializing in the
treatment of mitral and/or tricuspid regurgitation to assess patient risk and anatomical
suitability.
4.2 Precautions After Use
• Long-term durability has not been established for the implant. Regular medical follow-up is
advised to evaluate implant performance.
• Short-term anticoagulation therapy may be necessary after valve repair with the PASCAL
device. Prescribe anticoagulation and other medical therapy per institutional guidelines.
5.0 Potential Adverse Events
Complications associated with standard cardiac catheterization, the use of anesthesia and use of
the PASCAL system could lead to the following outcomes: conversion to open surgery, emergent
or non-emergent reoperation, explant, permanent disability, or death. Physicians are encouraged
to report suspected device related events to Edwards or the assigned hospital authorities.
The following anticipated adverse events have been identified as possible complications of the
PASCAL procedure:
• Abnormal lab values
• Allergic reaction to anesthetic, contrast, heparin, Nitinol
• Anemia or decreased Hgb, may require transfusion
• Aneurysm or pseudoaneurysm
• Angina or chest pain
• Anaphylactic shock
• Arrhythmias atrial (i.e. AF, SVT)
• Arrhythmias ventricular (i.e. VT, VF)
• Arterio-venous fistula
• Atrial septal injury requiring intervention
• Bleeding
• Cardiac arrest
• Cardiac failure
• Cardiac injury, including perforation
• Cardiac tamponade/pericardial effusion
• Cardiogenic shock
• Chordal entanglement or rupture that may require intervention
• Coagulopathy, coagulation disorder, bleeding diathesis
• Conduction system injury which may require permanent pacemaker
• Deep vein thrombosis (DVT)
• Deterioration of native valve (e.g. leaflet tearing, retraction, thickening)
• Dislodgement of previously deployed implant
• Dyspnea
• Edema
• Electrolyte imbalance
• Emboli/embolization including air, particulate, calcific material, or thrombus
• Endocarditis
• Esophageal irritation
• Esophageal perforation or stricture
• Exercise intolerance or weakness
• Failure to retrieve any PASCAL system components
• Fever
• Gastrointestinal bleeding or infarct
• Heart failure
• Hematoma
• Hemodynamic compromise
• Hemolysis
• Hemorrhage requiring transfusion or intervention
• Hypertension
• Hypotension
• Implant deterioration (wear, tear, fracture, or other)
• Implant embolization
• Implant malposition or failure to deliver to intended site
• Implant migration
• Implant thrombosis
• Infection
• Inflammation
• LVOT obstruction
• Mesenteric ischemia
• Multi-system organ failure
• Myocardial infarction
• Nausea and/or vomiting
• Nerve injury
• 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 0.035 inch (0.89 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 8.
7.3.2 Stabilizer
Step Procedure
1
Remove Stabilizer components from packaging and inspect for
damage.
2
Assemble the Stabilizer as necessary as seen in Figure 6.
2