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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

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COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC Back to Search Results
Catalog Number ZIV5-125-7-4.0
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
The stent is kinked and cannot fit the wire guide in the stent.Stent has been changed patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: the event of complaint dates back more than a month and i don¿t have more details than the complaint report from pharmacist.More if we look the cause of this complaint ( the stent is kinked and cannot fit the wire guide in the stent ) many of you questions list are not relevant expect q5 : yes devices kinked.
 
Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Cancellation report being submitted, complaint was reassessed as not reportable following device evaluation.Outer sheath was found to be kinked not the stent.Lab evaluation completed on 26jan2021, the following was noted: kink observed approx 54.8cm from white connection cap on outer sheath.Slight kink observed approx 5.0cm from the distal white tip along the outer sheath.Device flushed as expected.0.018" wire guide could not pass the kinks on the outer sheath.
 
Event Description
Cancellation report being submitted, complaint was reassessed as not reportable following device evaluation being completed on 26-jan-2021.Outer sheath was found to be kinked not the stent.The stent is kinked and cannot fit the wire guide in the stent.Stent has been changed.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: the event of complaint dates back more than a month and i don¿t have more details than the complaint report from pharmacist.More if we look the cause of this complaint ( the stent is kinked and cannot fit the wire guide in the stent ) many of you questions list are not relevant expect q5 : yes devices kinked.
 
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Brand Name
ZILVER 518 VASCULAR SELF-EXPANDING STENT
Type of Device
NIO STENT, ILIAC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11273462
MDR Text Key232625846
Report Number3001845648-2021-00047
Device Sequence Number1
Product Code NIO
UDI-Device Identifier10827002331300
UDI-Public(01)10827002331300(17)230429(10)C1728590
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2023
Device Catalogue NumberZIV5-125-7-4.0
Device Lot NumberC1728590
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2020
Event Location Hospital
Initial Date Manufacturer Received 01/06/2021
Initial Date FDA Received02/03/2021
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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