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Summary of Contents for St. Jude Medical TFGT-19A
- Page 1 Trifecta™ Valve with Glide™ Technology (GT) TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, TFGT-29A Instructions for Use...
- Page 2 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St.
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Page 3: Indications For Use
Mean Implanted Number (mm) (mm) (mm) (mm) Height* (mm) TFGT-19A TFGT-21A TFGT-23A TFGT-25A TFGT-27A TFGT-29A *Implanted height differs from total height since the Trifecta GT cuff is compressed when it is sutured into place, as observed through simulated bench testing of all Trifecta GT valve sizes Figure 1. - Page 4 Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure) Individuals requiring hemodialysis Do not use if: The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration. The expiration date has elapsed.
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Page 5: Adverse Events
CAUTION: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength. Adverse Events The Trifecta™ Valve with Glide™ Technology is based upon the Trifecta™ Valve design. Therefore, a previous clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve with Glide Technology. - Page 6 [One-Sided Upper 95% % [95% CI] % [95% CI] Thromboembolism 2.7% (27) 1.90% (16) [2.88%] 96.2% [94.7%, 97.2%] 92.9% [88.5%, 95.6%] Valve Thrombosis 0.0% (0) 0.00% (0) [0.35%] 100.0% [100.0%, 100.0%] 100.0% [100.0%, 100.0%] Major Bleed 8.0% (81) 2.61% (22) [3.72%] 90.4% [88.3%, 92.2%] 86.0% [81.0%, 89.8%] 1.4% (14)
- Page 7 Table 5. Effectiveness Outcomes, NYHA Functional Classification: 1 year Follow-up Subjects with both preoperative and 1 year NYHA measurements, N=606; n =number per subgroup NYHA Class N=606 Preoperative 1 Year % (n % (n 5.6% 85.3% 45.4% 13.5% 45.0% 1.2% 4.0% 0.0% 100.0%...
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Page 8: Packaging And Storage
Flexible Extension Handle Model EX-05 Optional handles may not be available in all locations. Please contact your local St. Jude Medical representative. Directions for Use Sizing the Valve CAUTION: Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizers. - Page 9 Figure 3. Sizing the valve The replica end of the TF2000 sizer may be used to visualize placement of the sewing cuff above the annulus and to confirm the fit of the valve in the supra-annular space. CAUTION: Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve. Pre-Implant Handling The valve is supplied in a storage jar with a screw-cap closure and tamper-evident seal.
- Page 10 NOTE: To prevent cross-threading, keep the holder handle perpendicular to the valve holder during attachment. Remove the valve from the jar. NOTE: The leaflets only coapt upon closure during the cardiac cycle. See leaflet outflow view illustration (page 8). CAUTION: Do not handle the valve with unprotected forceps. Do not use cutting edge needles or sharp instruments. Never handle the leaflet tissue.
- Page 11 Figure 6. Slide the retaining collar off the valve holder Rinse Procedure CAUTION: Do not implant the valve without thoroughly rinsing as directed. Within the sterile field prepare two sterile basins with a minimum of 500 mL of sterile isotonic saline in each basin. Holding the valve by the handle, fully immerse the valve, the valve holder, and the portion of the holder handle that was submerged in the valve storage solution, in the sterile isotonic saline solution in the first basin.
- Page 12 Patient Counseling Information Prophylactic antibiotic treatment should be considered for all patients undergoing dental procedures. St. Jude Medical publishes a patient brochure. Copies of this booklet are available through your St. Jude Medical sales representative. Disposal This instructions for use is recyclable. Dispose of all packaging materials as appropriate. Dispose of valves and accessories per standard solid biohazard waste procedures.
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Page 13: Limited Warranty
Limited Warranty St. Jude Medical (SJM) warrants that reasonable care has been used in the manufacturing of this device. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, WHETHER EXPRESS OR IMPLIED BY... - Page 14 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Confirmite Europeenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.
- Page 18 Manufacturer: Australian Sponsor: St. Jude Medical St. Jude Medical Australia Pty. Limited 177 County Road B, East 17 Orion Road St. Paul, MN 55117 USA Lane Cove NSW 2066 +1 855 478 5833 Australia +1 651 756 5833 Manufacturing Site:...
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