Catalog Number EVO-25-30-10-C |
Device Problems
Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 09/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this event is currently being evaluated.A follow up report will be submitted with the final device investigation conclusions.The device involved in this event is currently being evaluated.A follow up report will be submitted with the final device investigation conclusions.
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Event Description
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The physician encountered difficulty during the deployment of the evolution colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.
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Manufacturer Narrative
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This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the physician encountered difficulty during the deployment of the evolution® colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided '.Then the stent retracted from the patient together with the delivery system.' it was believed that the delivery system was removed from the patient with the stent partially deployed.This incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the physician encountered difficulty during the deployment of the evolution® colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided '.Then the stent retracted from the patient together with the delivery system.' it was believed that the delivery system was removed from the patient with the stent partially deployed.This incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.
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Event Description
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This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional mfg narrative-notes section for this justification.
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Search Alerts/Recalls
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