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

Model Number	G48025
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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
The physician attempted to place the stent to treat the stricture of the horizontal part of duodenum, but a distal side of the stent was not fully expand during deployment.Therefore, he retracted the stent into the sheath for the second try.However because the same thing occurred also at the second attempt of deployment, another evo- (9cm) was used instead to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
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).This follow up report is being submitted to cancel the initial report.A conservative approach was taken in initially assessing this complaint and was reported based on the malfunction precedence "deployment issue that results in the exposed stent removed from the patient".The device evaluation confirmed that there was no stent exposure or partially deployed stenta, the complaint has been re-assessed based on "unable to deploy stent" this failure mode is low risk (iia) and therefore no longer meets the fda mdr reporting requirements based on a malfunction precedence or malfunction report.
Event or Problem Description
This follow up report is being submitted to cancel the initial mdr report.The physician attempted to place the stent to treat the stricture of the horizontal part of duodenum, but a distal side of the stent was not fully expand during deployment.Therefore, he retracted the stent into the sheath for the second try.However because the same thing occurred also at the second attempt of deployment, another evo- (9cm) was used instead to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 7457322
• Report Number: 3001845648-2018-00184
• Device Sequence Number: 1704750
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)181003(10)C1279083
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1