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IFU, TENDYNE
TM
Mitral Valve System
Page 12 of 284
•
Bleeding complications
•
Blood loss which may require transfusion
•
Cardiac arrest
•
Cardiac perforation
•
Conduction defect with or without need for
pacemaker
•
Cardiac arrhythmia, atrial or ventricular
•
Damage to cardiac tissue and/or structures
•
Death
•
Decreased LV function and/or cardiac output
•
Device embolism
•
Device erosion, migration or malposition
•
Device thrombosis
•
Embolism (air, blood clot, calcium, tissue, etc.)
•
Endocarditis
•
Esophageal irritation, stricture, or perforation
•
Fever
•
Foreign body response
•
Heart Failure, new or worsening
•
Hematoma
•
Hemolysis
•
Hypotension
•
Infection / Sepsis
•
Leaflet, chordal, papillary or ventricular rupture
(resulting from mitral valvuloplasty, if
performed)
•
Liver failure
•
Mitral valve injury
•
Mitral valve prolapse / stenosis
•
Myocardial infarction
•
Obstruction
•
Pain
•
Pleural effusion
•
Pulmonary embolism
•
Pulmonary hypertension
•
Paravalvular leak
•
Pericardial effusion / tamponade
•
Renal insufficiency or failure
•
Respiratory difficulty, insufficiency or failure
•
Stroke or transient ischemic attack
•
Tear or damage to device
•
Vascular and access-related complications
•
Worsening of mitral regurgitation (MR)
8.
How Supplied
8.1.
Sterile
The valve is supplied sterile and non-pyrogenic for single
use only. The valve is sterilized with and stored in
glutaraldehyde solution for preservation of porcine
tissue components. The valve is supplied in a storage
container with a screw cap closure and a tamper-
evident seal.
The Apical Pad is supplied sterile and non-pyrogenic for
single use only. The Apical Pad is sterilized with ethylene
oxide gas.
The Tendyne
TM
Loading System, Tendyne Delivery
System, Tendyne Pad Positioning System, and Tendyne
Retrieval System are supplied sterile for single use only.
They are sterilized with ethylene oxide gas.
Additional system components provided sterile are
single use only and include the Tendyne Stand
Components (angled clip, rotating clip, rotating clip
head, bottom loading clip, thumb screws), 1-way and 3-
way stopcocks, hemostasis adapter, Tuohy- Borst valve,
valve pocket de-air tube, tether flushing assembly,
verification tether, extension tube, tether clip, and
pressure transducer. They are sterilized with ethylene
oxide gas.
8.2.
Non-Sterile
The Tendyne
TM
Stand and Tendyne Weight are provided
non-sterile and are reusable. These components must
be cleaned and sterilized prior to each use. Follow the
cleaning and sterilization instructions provided in
Section 10.14.
Содержание Tendyne TENDV-LP-29L
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Страница 205: ...Bruksanvisning TENDYNETM mitralklaffsystem Side 205 av 284 VEDLEGG A...
Страница 232: ...Instru es de utiliza o sistema de v lvula mitral TENDYNETM P gina 232 de 284 ANEXO A...
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