Model Number 39200 |
Device Problems
Positioning Failure (1158); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/30/2020 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.The severely stenosed target lesion was located in the left femoral artery.After a 7f non-boston scientific sheath and a 0.035 amplatz guide wire crossed the lesion, a 7x60x120 epic vascular stent was advanced for treatment.After the stent reached the lesion, the handle roller could not be rotated and the stent could not be deployed even after repeated attempts.When the device was removed, the middle of the stent struts were found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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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 sheath is kinked 10cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the deployment issues.
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Event Description
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It was reported that stent damage occurred.The severely stenosed target lesion was located in the left femoral artery.After a 7f non-boston scientific sheath and a 0.035 amplatz guide wire crossed the lesion, a 7x60x120 epic vascular stent was advanced for treatment.After the stent reached the lesion, the handle roller could not be rotated and the stent could not be deployed even after repeated attempts.When the device was removed, the middle of the stent struts were found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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Search Alerts/Recalls
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