Potential Adverse Events - Edwards PASCAL Gebrauchsanweisung

Applicable to mitral patients only:
• Flail width > 15 mm and/or flail gap > 10 mm
• Transseptal puncture height < 3 . 5 cm
• LA diameter ≤ 35 mm
• Presence of two or more significant jets
• Presence of one significant jet in the commissural area
• Mitral valve area (MVA) < 4 . 0 cm
• LVEDD > 8 . 0 cm
Applicable to tricuspid patients only:
• Presence of primary non-degenerative tricuspid disease
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
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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
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