BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Model Number 24657 |
Device Problems
Premature Activation (1484); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that the stent inadvertently deployed.This 7x60, 130 cm eluvia drug-eluting vascular stent system was selected for use in a runoff procedure for peripheral artery disease.The stent system was loaded over a non-boston scientific guidewire.As soon as the stent was loaded on the wire, it was difficult to advance; therefore, the stent system was removed from the wire.However, when pulling it off the wire the stent inadvertently deployed.It was noted that the stent never entered the patients body.The procedure was completed with a new stent and there were no patient complications.
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Event Description
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It was reported that the stent inadvertently deployed.This 7x60, 130 cm eluvia drug-eluting vascular stent system was selected for use in a runoff procedure for peripheral artery disease.The stent system was loaded over a non-boston scientific guidewire.As soon as the stent was loaded on the wire, it was difficult to advance; therefore, the stent system was removed from the wire.However, when pulling it off the wire the stent inadvertently deployed.It was noted that the stent never entered the patients body.The procedure was completed with a new stent and there were no patient complications.
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Manufacturer Narrative
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Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system was inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 15mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed that the stent was partially deployed.
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