Model Number 20300 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/26/2019 |
Event Type
malfunction
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Event Description
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It was reported that inadvertent stent deployment occurred.A 5x120x120 epic stent was selected for use.However, when the physician removed the stent from the package, the stent suddenly opened.The device was attempted to be inserted in the guide but was unsuccessful.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.:returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is sticking out 2.1cm past the distal end of the middle sheath.The inner liner is extended 8.4cm from the distal end of the middle sheath and there are multiple kinks to the inner liner.Microscopic examination revealed no additional damages.The yellow lock is missing.There is blood in the middle sheath.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling.Inspection of the remainder of the device presented no damage or irregularities.
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Event Description
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It was reported that inadvertent stent deployment occurred.A 5x120x120 epic stent was selected for use.However, when the physician removed the stent from the package, the stent suddenly opened.The device was attempted to be inserted in the guide but was unsuccessful.No patient complications were reported.
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Search Alerts/Recalls
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