Catalog Number EVD35-06-150-150 |
Device Problems
Fracture (1260); Activation, Positioning or Separation Problem (2906)
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Patient Problems
Injury (2348); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/28/2019 |
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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Physician was attempting to implant an everflex entrust self expanding stent with a 7fr sheath to treat a severely calcified lesion in the right proximal common iliac to sfa with a chronic total occlusion (cto-100%).The vessel diameter and lesion length was 5mmand 120mm respectively.The vessel was severely tortuous.There was no damage noted to packaging.No issues noted when removing the device from the hoop/tray.Device was prepped per ifu with no issues identified.There was deployment issue, with the stent partially deployed.Resistance was encountered during delivery to lesion with force applied.The device did not pass through a previously deployed stent.There was no damage to the deployment mechanisms or device handle prior to deployment issue.The thumbscrew/lock-pin was checked for securement prior to procedure.The lesion was pre dilated using a 5.0 balloon.It was reported that stent was advanced partially through a distal sfa and popliteal lesion.Stent partially deployed approximately 20mm of the stent.The stent was dr agged through the sheath and retrieved.After stent retrieval, it was discovered that part of the stent (the part that had been deployed), had separated and was left in the contra lateral side somewhere between the skin and tissue.Patient was stable but was later transferred to the hospital due to groin bleed.Ct was done and patient groin stopped bleeding at hospital there was no other adverse event.Another stent over 035 wire was used to complete the procedure.There was no patient injury reported.
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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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