Model Number 26930 |
Device Problems
Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/21/2020 |
Event Type
malfunction
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Event Description
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It was reported that the stent partially deployed and removal difficulties occurred.A 16x120mm,100cm vici self expanding stent was selected for use to treat the lesion.During deployment of the stent, it became caught on a previously placed vici stent on the right side near the confluence.This prevented the stent to fully deploy.Attempts were made to remove the partially deployed stent; however, the stent was getting caught on another placed stent.Eventually the physician was able to remove the stent and the procedure was completed with a new stent of a different size.No patient complications were reported.
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Event Description
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It was reported that the stent positioning difficulties were encountered.A 16x120mm,100cm vici self expanding stent was selected for use to treat the lesion.During deployment of the stent, it became caught on a previously placed vici stent on the right side near the confluence.This prevented the stent to fully deploy.Attempts were made to remove the partially deployed stent; however, the stent was getting caught on another placed stent.Eventually the physician was able to remove the stent and the procedure was completed with a new stent of a different size.No patient complications were reported.
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Manufacturer Narrative
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Correction to h6 device codes.Initially reported as activation, positioning or separation problem 2906 the h6 code is corrected to positioning problem 3009.Device evaluated by manufacturer: the device was received with the stent partially deployed.The stent could not be fully deployed due to severe damage to the outer shaft of the device.A visual and tactile examination of the tip identified no damage or issues with the tip of the device.A visual and tactile examination of the shaft identified severe kinking and a complete break of the outer shaft of the device located approximately 100mm proximal of the distal end of the shaft.This type of damage is consistent with excessive force being applied to the device.
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Search Alerts/Recalls
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