Model Number H965SCH647130 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the carotid artery.A 10.0mmx31mm carotid wallstent¿ was advanced for treatment; however the stent was found damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was received with the stent fully constrained on the delivery device.No damage was evident.The investigator deployed the stent without issue.The stent was visually and microscopically examined and no issues were identified.A visual and tactile inspection identified no issues along the length of the device.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the carotid artery.A 10.0mmx31mm carotid wallstent¿ was advanced for treatment; however the stent was found damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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