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Model Number 26280 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
Injury
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Event Description
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It was reported that the stent foreshortened.The 50% stenosed lower extremity vein was treated with balloon expansion and venous stenting.A 14mm x 90m wallstent uni stent was implanted.Another 14mm x 90m wallstent uni stent was planned.While delivering the second stent normally, half of the stent overlapped the previously placed one, and it was deployed slowly.When the stent was fully deployed, it appeared that the stent was severely shortened.The overlapped portion of the two stents was less than 1cm.A balloon was used, and the two stents detached from each other.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination found the stent had been deployed.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found the shaft to be kinked at approximately 13mm proximal from the distal tip.This type of damage is consistent with excessive force being applied to the device.
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Event Description
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It was reported that the stent foreshortened.The 50% stenosed lower extremity vein was treated with balloon expansion and venous stenting.A 14mm x 90m wallstent uni stent was implanted.Another 14mm x 90m wallstent uni stent was planned.While delivering the second stent normally, half of the stent overlapped the previously placed one, and it was deployed slowly.When the stent was fully deployed, it appeared that the stent was severely shortened.The overlapped portion of the two stents was less than 1cm.A balloon was used, and the two stents detached from each other.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.
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Search Alerts/Recalls
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