Catalog Number EVX35-05-080-120 |
Device Problems
Positioning Problem (3009); Activation Problem (4042)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 06/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the physician was using an everflex entrust stent to treat a severely calcified, 80% stenotic lesion in the mid superficial femoral artery(sfa).There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.No embolic protection was used.The device did not pass through a previously deployed stent and no resistance was encountered and no excessive force was applied during delivery of the device to the lesion.The thumbscrew was checked for securement prior to the procedure and the lock-pin was removed just before deployment.It was reported that the stent partially deployed in an unintended lesion.The physician deferred to surgery to remove the stent and treat the severely stenotic sfa.The patient is currently doing well.
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Manufacturer Narrative
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Additional information: the stent was removed from the patient's artery via open surgery.The patient has been discharged and is currently doing well.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the device was successfully advanced to the target lesion prior to removing the lock tube and attempted to deploy.Deployment difficulties were encountered.The stent is reported to have wrinkled.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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