Model Number 425 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Code Available (3191)
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Event Date 11/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device has not yet been returned to numed for evaluation.If the device is returned and anything is found that will affect or change this report, a follow-up mdr report will be sent.The device was being used off-label.This device is only approved for use in coarctation of the aorta.They physician was using this device for lpa stenting, which is an off-label use.Stent migration is a known potential complication for stents and is listed in the instructions for use.
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Event Description
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As per the report from the foreign manufacturer and physician - "after deployment, lpa stent embolized to mpa upon removal of wire.Attempts to redeploy it in lpa or rpa failed.The stent was then snared out".
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Manufacturer Narrative
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The device has not yet been returned to numed for evaluation.If the device is returned and anything is found that will affect or change this report, a follow-up mdr report will be sent.The device was being used off-label.This device is only approved for use in coarctation of the aorta.They physician was using this device for lpa stenting, which is an off-label use.Stent migration is a known potentital complication for stents and is listed in the instructions for use.Update: the device was returned on 01/10/2018.The stent is too deformed for analysis.Additional information from the physician was also returned.The physician stated that he mounted this stent on a z-med catheter.It is likely that the stent was not fully expanded to the desired diameter of 14mm.A letter from the physician states that the balloon was inflated to 4 atm.14mm z-meds have a rated burst pressure of 6 atm.There is a warning in the z-med ifu that states : this catheter is not intended for use with stents.".
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Event Description
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As per the report from the foreign manufacturer and physician - "after deployment, lpa stent embolized to mpa upon removal of wire.Attempts to redeploy it in lpa or rpa failed.The stent was then snared out.".
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Search Alerts/Recalls
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