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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 ZIV5-18-125-10-80
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
As reported to customer relations via complaint email "i am reporting a defective product for university of (b)(6).The event took place on 11/13 and i was informed about it on 11/16.They will not be reporting this to the fda, they do not need a replacement product, you can send an acknowledgement letter to me, and i¿ll forward it on to the account.The product is not available for return.(b)(6) g43798/c2073988 physician: dr.(b)(6).Description: ¿the stent broke¿ if you can send me the follow-up questions, i will ask the customer.I was not given much detail about this incident.Are images of the device or procedure available? n/a, yes, no at what stage of the procedure did the complaint occur? unpacking or preparation of the device, insertion, stent placement, removing the introducer.Details of access sheath used (name, fr size, length)? what was the target location for the stent? was the product inspected for kinks or damage before use? n/a, yes, no was the device used percutaneously? n/a, yes, no was the device flushed through both flushing port before the procedure, as per ifu? n/a, yes, no was pre-dilation performed ahead of placement of the stent? n/a, yes, no was post-dilation performed after the placement of the stent? n/a, yes, no details of the wire guide used (name, diameter, hyrdophyllic)? did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered was resistance encountered when advancing the wire guide to the target location? n/a, yes, no was resistance encountered when advancing the delivery system to the target location? n/a, yes, no how did the physician deal with this resistance? was the approach ipsilateral or contralateral? n/a, ipsilateral, contralateral if contralateral, was the bifurcation angle steep? n/a, yes, no did the tip of the delivery system cross the target location? n/a, yes, no was the delivery system tracked around a tight angle in the patient anatomy? n/a, yes, no was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no was the handle pulled towards the hub during deployment? n/a, yes, no was the delivery system pushed during deployment? n/a, yes, no was the stent deployed smoothly / without resistance? n/a, yes, no if no, please detail any difficulty experienced during deployment: what artery was the stent placed in? was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a, yes, no did the patient have any pre-existing conditions? n/a, yes, no if yes, please specify: did the patient require any additional procedures as a result of this event? n/a, yes, no what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no please specify if yes.
 
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.
 
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
Supplemental report is being submitted due additional information received on 13-jan-2024: gpn has been updated based on the udi.Rpn corrected to ziv5-18-125-10-80.
 
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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
Manufacturer (Section G)
COOK IRELAND
holstein campus kiel
arnold- keller str- 3
limerick
Manufacturer Contact
sinead o'leary
holstein campus kiel
arnold- keller str- 3
limerick 
MDR Report Key18319680
MDR Text Key330393739
Report Number3001845648-2023-00902
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/13/2024
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 Catalogue NumberZIV5-18-125-10-80
Device Lot NumberC2073988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2023
Event Location Hospital
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/13/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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