MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23126
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
This file is related to (b)(4) (3001845648-2018-00605) and was created to capture the off label use noted in the original file.Stent in stent ¿ off label use.
Additional Manufacturer Narrative
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: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.This follow up mdr report is being submitted to cancel the initial report.Initial reporting was based on a conservative assessment of "off label use".However additional information was received confirming that the previously placed stent and the evo stent were the same diameter.Additionally in this case the physician placed an additional stent through the lumen of the previously placed stent not through the side wall.This file does not represent "off label" use in accordance to our ifu.Ifu0056-5 states "this device is not intended to be deployed through the wall of a previously placed or existing metal stent." based on the above information this event has been re-assessed and this file will be cancelled as it no longer meets the criteria of a complaint.This report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report as per section 803.50 of 21 cfr 803.No adverse effects to the patient was reported as occurring.
Event or Problem Description
This follow up mdr report is being submitted to cancel the initial report.This file is related to pr (b)(4) and was created to capture the off label use noted in the original file.Stent in stent ¿ off label use.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8370685
• Report Number: 3001845648-2019-00076
• Device Sequence Number: 1097923
• Product Code: FGE
• UDI-Device Identifier: 10827002231266
• UDI-Public: (01)10827002231266(17)190828(10)C1393339
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: G23126
• Device Catalogue Number: EVO-8-9-10-B
• Device Lot Number: C1393339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1