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https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414428
The retroflex 3 delivery system was returned to edwards for evaluation in a used condition. Visual and dimensional inspections were performed. Visual inspection revealed a longitudinal tear along the length of the balloon still attached to the catheter.
https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041c.pdf
Transcatheter Heart Valve with the RetroFlex 3 Edwards Delivery System Instructions for Use The following table identifies the bioprosthesis size that should be Caution: Federal (USA) law restricts this device used based on native valve annulus size, as measured by to sale by or on the order of a physician. transesophageal echocardiography (TEE).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4251339/
We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards S apien ® valve system. The procedure was complicated by rupture of the valve-deployment balloon, with separation and retention of the nose cone of the RetroFlex 3 ® delivery system in the iliac artery. Our endovascular retrieval of the equipment ...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...
http://www.retroflex.com/reverse-angle-doctor-blade-systems-radbs/
Retroflex engineers and builds the Reverse Angle Doctor Blade System (RADBS) with superior features that deliver consistent performance without constant adjustments or maintenance. Through years of on-press testing, the Retroflex RADBS has become one of the most respected doctor blade systems on the market today when replacing older systems or ...
http://mjr.barnabasheart.org/uploads/8/4/0/0/8400188/______199470004_ifu_110311.pdf
The RetroFlex 3 delivery system includes a rotating wheel within the handle for articulation of flex catheter, a tapered tip at the distal end of the delivery system to facilitate crossing the native valve, a balloon for deployment of the bioprosthesis, and radiopaque markers as indicated in Figure 2. Black dots indicate position of radiopaque ...
https://www.edwards.com/gb/devices/Heart-Valves/Transcatheter-Sapien-3
Now approved for aortic and mitral valve-in-valve procedures. The SAPIEN 3 valve is the only valve approved for valve-in-valve procedures in both the aortic and mitral positions, allowing patients at high or greater surgical risk to avoid an additional open heart procedure.
https://thij.org/doi/abs/10.14503/THIJ-13-3447
We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards Sapien® valve system. The procedure was complicat...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...
https://www.ncbi.nlm.nih.gov/pubmed/25593532
Dec 01, 2014 · Percutaneous management of RetroFlex 3 balloon rupture and separation of the Edwards Sapien delivery system. Green KD, Waked A, Majeed U, Fudim M, Robbins MA, Crenshaw M, Zhao D. We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards Sapien(®) valve ...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...
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