Model Number 26280 |
Device Problems
Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that a stent partially deployed and was damaged after it was implanted.A 14mm x 90mmx 75cm, 9french wallstent uni self expanding stent was selected to treat 75% stenosis in the iliac vein.The stent was advanced along the guidewire to the lesion and it was positioned accurately in the lesion.During deployment, the stent partially deployed.It could not deploy and could not be withdrawn.The physician pulled out the delivery shaft to deploy stent.The stent was severely elongated and deformed inside the patient's body.The procedure was completed with a different device.There were no patient complications reported.
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Manufacturer Narrative
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Device eval by mfr: the device was received and analysis was completed.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned for analysis.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified a shaft kink located approximately 265mm distal from the distal end of the t connector.
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Event Description
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It was reported that a stent partially deployed and was damaged after it was implanted.A 14mm x 90mmx 75cm, 9french wallstent uni self expanding stent was selected to treat 75% stenosis in the iliac vein.The stent was advanced along the guidewire to the lesion and it was positioned accurately in the lesion.During deployment, the stent partially deployed.It could not deploy and could not be withdrawn.The physician pulled out the delivery shaft to deploy stent.The stent was severely elongated and deformed inside the patient's body.The procedure was completed with a different device.There were no patient complications reported.The device was received and analysis was completed on 25jan2022.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned for analysis.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified a shaft kink located approximately 265mm distal from the distal end of the t connector.
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Search Alerts/Recalls
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