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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUMED, INC. CP STENT; AORTIC STENT
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NUMED, INC. CP STENT; AORTIC STENT Back to Search Results
Model Number 425
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Code Available (3191)
Event Date 11/15/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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".
 
Manufacturer Narrative
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.".
 
Event Description
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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Brand Name
CP STENT
Type of Device
AORTIC STENT
Manufacturer (Section D)
NUMED, INC.
2880 main street
hopkinton NY 12965
MDR Report Key8161187
MDR Text Key130259871
Report Number1318694-2018-00017
Device Sequence Number1
Product Code PNF
Combination Product (y/n)N
PMA/PMN Number
P150028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/31/2021
Device Model Number425
Device Catalogue NumberCP8Z22
Device Lot NumberCP-0757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2019
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
Patient Weight15
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