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Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft System


Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft System
FRIDLEY (dpa-AFX) - Medtronic plc has recalled unused Medtronic Valiant Navion thoracic stent graft system globally, according to the U.S. Food and Drug Administration. The Irish medical technology company also informed physicians to immediately cease use of the device until further notice.
The company initiated the recall following information obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.
Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. It was found that seven out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance.

Ireland , Irish , Drug-administration , Medtronic , Medtronic-valiant-navion , Valiant-evo-global-clinical-trial , Valiant-evo-global-clinical , Valiant-navion , Recalls , Unused , Valiant

Medtronic Voluntarily Recalls Unused Valiant Navion Thoracic Stent Graft System

FRIDLEY (dpa-AFX) - Medtronic plc (MDT) said Wednesday it has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and also informed physicians to

Drug-administration , Medtronic , Medtronic-valiant-navion , Valiant-evo-global-clinical-trial , Valiant-evo-global-clinical , Voluntarily , Recalls , Unused , Valiant , Navion , Thoracic

Detailed text transcripts for TV channel - CNN - 20180116:20:52:00

routine, working on his diet. those things will make him much healthier although his health is good right now. dr. gupta? >> some pretty intensive tests -- >> it was a trans thoracic. >> was there something you were worried about specifically in the ct scan? >> no. not at all. we did the ct scan because we were debating, i any background information on him. i didn't have old chest x-rays to look at or anything so i was going to initially get a chest x-ray and be done with it but it is so easy nowadays. it just takes a minute or. two about as much time to get a cat scan in the way we did as a chest x-ray and it gives you more information about other structures in the chest so it made more sense to get the ct done. with regard to the echocardiogram, one of the major reasons did i that, i wanted to prescribe an exercise program

Things , Brigadier-general , Diet , Health , Gupta , Something , Tests , Ct-scan , Background-information , Thoracic , Anything , Chestx-ray

Detailed text transcripts for TV channel - FOXNEWS - 20180116:20:38:00

system. eyes, the president's uncorrected visual acuity is 20/30 bilaterally with corrected vision of 20/20. his visual fields were normal. his intraocular pressures were normal and no ocular pathology was discovered. head, ears, nose and throat, normal exam of the head, ears, nose, mouth and throat. dental exam, he has healthy teeth and gums. no other dental findings. neck, normal thyroid exam. his carotid armories were normal. a ct of the chest demonstrated no pathology. cardiac exam. heart exam was normal. no murmurs or other heart sounds were noted. his ecg or commonly ekg was normal sinus rhythm with a right of 71. he had a normal axis and no other findings. he has a trans thoracic echo

Donaldj-trump , System , Intraocular-pressures , Vision , Eyes , S-uncorrected-visual-acuity , Fields , 20-30 , 20 , Prevnar , Exam , Findings

Detailed text transcripts for TV channel - FOXNEWS - 20180116:20:52:00

healthier than he is right now. although his health is excellent. dr. gupta? you want to answer one or -- >> there were some pretty intensive tests including a ct -- >> a trans thoracic. >> did he need to be sedated? something to be worried about? >> no, not at all. we got the committee today scan -- i didn't have any background information from him from a pulmonary standpoint. i did have old chest x-rays to look at. so i was going to initially just get a chest x-ray, be done with it. but it's so easy to whip in and just takes a few -- a minute or two, about as much time to get a cat scan the way we did as a chest x-ray and gives you more information. so made more sense to get the ct down. with regards to echo cardio gram. i wanted to prescribe an exercise program for the president. it made sense to get a good

Brigadier-general , Health , Tests , Ct , Gupta , One , Something , House-oversight-committee , Thoracic , Background-information , Chestx-rays , Standpoint

Detailed text transcripts for TV channel - MSNBC - 20180116:20:52:00

those things will make him much re healthier than he is now although his health is excellent right now. dr. gupta, you want to answer one or -- >> there were extensive tests including a scan of his chest -- >> trans-thoracic. >> did he need to be sedated at all, there was anything you were concerned about in the ct scan? >> not at all. we got the ct scan because we were debating. i didn't have background information on him at all from a pulmonary stand poichbt, didn't have old chest sprays to look at oar anything like that. i was going to initially get a chest spray and be done with it. it's easy nowadays to whip in, takes a minute or two, about as much time to get a cat scan as it does to get a chest spray and give you information about other structures in the chest. with regards to the ecocardiogram, one of the reasons i did that because i wanted to prescribe an exercise program for the president. so i think that, you know, it

Things , Dr , Tests , Chest , Health , Gupta , Scan , One , Anything , Ct-scan , Background-information , Didn-t

Wolf-20150501-17:53:00

memorial hospital the medical examiner in burlington county new jersey is joining us from philadelphia. thank you very much for joining us. as you heard, the state's attorney says freddie gray was injured in the hand because he was handcuffed shackled, and not wearing a seat belt as required. explain how the injury that eventually caused his death may have happened. >> well normally if a spinal cord injury causes immediate death, it's going to be up in the cervical area. that'll cause immediate death at that area or above. this injury must be below, either low cervical upper thoracic area. there may have been complications from it. cord swelling. he may have gotten pneumonia while in the hospital. if he hadn't had the injury he wouldn't have died. so the medical examiner -- ultimately this was a major injury and caused his death a week after he was arrested. >> so this medical examiner's report is crucial in this case right? >> absolutely.

Freddie-gray , States-attorney , Examiner , United-states , Hand , Burlington-county , Memorial-hospital , Philadelphia , New-jersey , Death , Injury , Seat-belt

Detailed text transcripts for TV channel - MSNBC - 20130711:11:16:00

before. >> the injury occurs between the thoracic and lumbar spine and the crushes the front of the vertebrae and can damage the spinal cord. >> reporter: sometimes use three point belts when the seat in front is too far away to provide protection. u.s. airlines have resisted three-point belts because they don't allow passengers to brace for impact and not required by the faa. we want to talk to you briefly about that lag time allegation an getting medics, ambulances to the crash scene. we talked to the fire department about that. they told us that the first ambulances on the scene were private ambulances, the fire department's ambulances arrived within 13 minutes, but the incident commander staged them away from the crash scene at first concerned that the plane was going to blow up. meanwhile, the pilot has told investigators he thought he saw a flash of light that blinded him at 500 feet. the investigator's are looking at that and also about whether

Injury , Front , Thoracic , Cord , Vertebrae , Lumbar-spine , Reporter , Passengers , Us- , Impact , Protection , Airlines

Detailed text transcripts for TV channel - CNN - 20100213:05:11:00

dr. wayne isom returns, chairman of thoracic and cardiac surgery. he performed heart surgery on david letterman, walter cronkite and me. dr. dean ornish, who is a consultant to president clinton. dr. sanjay gupta, cnn's medical correspondent and the lovely and talented jane seymour. she just attended the red dress event here in new york. she had a life-threatening condition linked to blood pressure. wayne isom, were you surprised at how well the president looked today and acted? >> no, not at all. that's routine, and you're a good example of that. i would expect him to go back strong. it sounds like that's his personality.

Dr , Wayne-isom , Cardiac-surgery , Heart-surgery , Returns , David-letterman , Chairman , Thoracic , Walter-cronkite , Dean-ornish , Larry-king , Event