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

Model Number	G43866
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: p050017/s002.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.
Event or Problem Description
As reported to customer relations: "discussion with staff nurse sounded like there was stent migration." additional information provided by dm on 24aug2018: "(b)(6) will forward what he has.We are trying to get ivus pics without phi as well." request forwarded from dm on behalf of physician on 24aug2018: "also, on top of the standard letter which gets sent can we have someone call dr.(b)(6) to discuss in further detail.Dr.(b)(6) was trained and has practiced extensively with cook product.This case certainly seems like an anomaly, and additional follow up would be valuable for both sides i believe.Thanks for any help you can offer with this follow up.".
Event or Problem Description
This report is being submitted as a cancellation report.As reported to customer relations: "discussion with staff nurse sounded like there was stent migration.".
Additional Manufacturer Narrative
510(k) number: p050017/s002.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: (b)(4).This file is related to (b)(4).It was initially indicated that 2 zilver stents had migrated.237406 addresses the first stent ziv6-35-80-8-40.Image review and event information confirmed that stent migration occurred for ziv6-35-80-8-40.However, additional information confirmed that the 2nd stent (ziv6-35-80-10-40) addressed in this file was placed as an intervention following the first device.The image review found this device in the distal common iliac artery and it was confirmed that this was the location intended and that it did not migrate.As a result, it is confirmed that this device did not malfunction and an mdr report is not required.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7860256
• Report Number: 3001845648-2018-00420
• Device Sequence Number: 16552428
• Product Code: NIO
• UDI-Device Identifier: 10827002438665
• UDI-Public: (01)10827002438665(17)200905(10)C1394723
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: G43866
• Device Catalogue Number: ZIV6-35-80-10-40
• Device Lot Number: C1394723
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 79