BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Model Number 24657 |
Device Problems
Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2022 |
Event Type
Injury
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Event Description
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It was reported that stent partial deployment requiring additional intervention occurred.The target lesion was located in a mildly tortuous and mildly calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was delivered contralaterally to treat the arterial disease.A normal amount of force was required to turn the thumbwheel and the thumbwheel was used until the white arrow was visible to deploy the stent, however, only 50% of the stent was deployed.When removing the deployment mechanism, the stent was then stretched to a longer length.As a result, the surgeon used two innova stents to line the stretched eluvia stent.There were no patient complications reported and the patient fully recovered after the procedure.
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Manufacturer Narrative
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H6: device code difficult to remove was removed.Device analysis by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open.The pull rack is separated 5.2cm from the proximal end of the nosecone.The sheath is twisted at the nosecone.There is a kink to the sheath 46cm from the nosecone.The proximal inner is prolapsed.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.
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Event Description
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It was reported that stent partial deployment requiring additional intervention occurred.The target lesion was located in a mildly tortuous and mildly calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was delivered contralaterally to treat the arterial disease.A normal amount of force was required to turn the thumbwheel and the thumbwheel was used until the white arrow was visible to deploy the stent, however, only 50% of the stent was deployed.When removing the deployment mechanism, the stent was then stretched to a longer length.As a result, the surgeon used two innova stents to line the stretched eluvia stent.There were no patient complications reported and the patient fully recovered after the procedure.
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Search Alerts/Recalls
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