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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

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COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC Back to Search Results
Model Number G43851
Device Problem Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # = p050017/s002 and s003.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
As reported to customer relations "the very tip of the deployment system detached from the remainder of the device.It did not break but it somehow disassembled.It came out over the wire with the rest of the device.The procedure had been successfully completed with the device in question.".
 
Event Description
As reported to customer relations "the very tip of the deployment system detached from the remainder of the device.It did not break but it somehow disassembled.It came out over the wire with the rest of the device.The procedure had been successfully completed with the device in question.".
 
Manufacturer Narrative
Pma/510(k) # = p050017/s002 and s003.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
As reported to customer relations "the very tip of the deployment system detached from the remainder of the device.It did not break but it somehow disassembled.It came out over the wire with the rest of the device.The procedure had been successfully completed with the device in question.".
 
Manufacturer Narrative
Pma/510(k) # = p050017/s002 and s003.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer.).Exemption number: e2016031 information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Manufacturer Narrative
Pma/510(k)#: p050017/s002 and s003.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) device evaluation the ziv6-35-80-7-40 d:evice of lot number: c1305426 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 25april2019.The peek was broken at the proximal side of pusher ring.There was a kink on the flexor, 15cm distal to white connector cap, which was related to the broken peek.Document review: prior to distribution all zilver ziv6-35-80-7-40 vascular devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (c1305426) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1305426.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause is kinking of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.The peek was broken at the proximal side of pusher ring.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
As reported to customer relations "the very tip of the deployment system detached from the remainder of the device.It did not break but it somehow disassembled.It came out over the wire with the rest of the device.The procedure had been successfully completed with the device in question.".
 
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Brand Name
ZILVER 635 VASCULAR SELF-EXPANDING STENT
Type of Device
NIO STENT, ILIAC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8514332
MDR Text Key142274577
Report Number3001845648-2019-00147
Device Sequence Number1
Product Code NIO
UDI-Device Identifier10827002438511
UDI-Public(01)10827002438511(17)191214(10)C1305426
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 06/10/2019
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 Date12/14/2019
Device Model NumberG43851
Device Catalogue NumberZIV6-35-80-7-40
Device Lot NumberC1305426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/18/2019
Event Location Hospital
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received04/15/2019
Supplement Dates Manufacturer Received03/18/2019
03/18/2019
03/18/2019
Supplement Dates FDA Received05/13/2019
06/10/2019
07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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