MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number	G48027
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k163468.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 including the investigation conclusions.
Event or Problem Description
As initially reported to customer relations: a patient of unknown age and gender underwent an upper endoscopy with placement of duodenal stent which the evolution duodenal controlled-release stent, g48027- qty.2 were used.(an additional file has been created to capture the second device) both stents were prepped correctly.Both were passed down the scope.When asked to deploy, the trigger was squeezed and the little plastic piece moved down the handle, but the catheter did not move and the stent did not deploy.There was an audible click with the second stent.The position was good and scope was straight inside.Dr.Reported the scope was not looped tight on the outside.This is the message that was sent to me [district manager] from the nurse.The reference to the little plastic piece on the handle is the indicator for where they are in the deployment.The procedure was completed by using a third stent.
Event or Problem Description
This follow up report is being submitted to cancel the initial mdr report.As initially reported to customer relations: a patient of unknown age and gender underwent an upper endoscopy with placement of duodenal stent which the evolution duodenal controlled-release stent, g48027- qty.2 were used.(an additional file has been created to capture the second device) both stents were prepped correctly.Both were passed down the scope.When asked to deploy, the trigger was squeezed and the little plastic piece moved down the handle, but the catheter did not move and the stent did not deploy.There was an audible click with the second stent.The position was good and scope was straight inside.Dr.Reported the scope was not looped tight on the outside.This is the message that was sent to me [district manager] from the nurse.The reference to the little plastic piece on the handle is the indicator for where they are in the deployment.The procedure was completed by using a third stent.
Additional Manufacturer Narrative
510(k) number: k163468.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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This report is being submitted as a cancellation report, file was reported initially based on a conservative assessment of device malfunction reporting precedence for this device family ¿flexor kinked/ stretched/ broken/ compressed¿.The device was returned and evaluated confirming no issue with the flexor of the device.The shuttle cap was found to be broken, the file has been re-assessed and has an overall risk category iia (low).This event has been re-assessed and 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.Complaints of this nature will continue to be monitored for potential emerging trends.
Additional Manufacturer Narrative
510(k) number: k163468.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 including the investigation conclusions.
Event or Problem Description
As initially reported to customer relations: a patient of unknown age and gender underwent an upper endoscopy with placement of duodenal stent which the evolution duodenal controlled-release stent, g48027- qty.2 were used.(an additional file has been created to capture the second device) both stents were prepped correctly.Both were passed down the scope.When asked to deploy, the trigger was squeezed and the little plastic piece moved down the handle, but the catheter did not move and the stent did not deploy.There was an audible click with the second stent.The position was good and scope was straight inside.Dr.Reported the scope was not looped tight on the outside.This is the message that was sent to me [district manager] from the nurse.The reference to the little plastic piece on the handle is the indicator for where they are in the deployment.The procedure was completed by using a third stent.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8514469
• Report Number: 3001845648-2019-00145
• Device Sequence Number: 1724296
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)200920(10)C1541865
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2019

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: 09/20/2020
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1541865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 03/20/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/13/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1