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

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.".

• 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 Key: 8514332
• MDR Text Key: 142274577
• Report Number: 3001845648-2019-00147
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438511
• UDI-Public: (01)10827002438511(17)191214(10)C1305426
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Date: 12/14/2019
• Device Model Number: G43851
• Device Catalogue Number: ZIV6-35-80-7-40
• Device Lot Number: C1305426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 03/18/2019; 03/18/2019; 03/18/2019
• Supplement Dates FDA Received: 05/13/2019; 06/10/2019; 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR