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	Delivery System Failure (2905)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # "k101530 and 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 pending, a follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence of 'flexor kinked/stretched/broke/compressed'.The deployment handle broke during use.
Additional Manufacturer Narrative
Pma/510(k) # "k101530 and k163468." exemption number: e2016031 (b)(4).The complaint information reported was as follows: ¿the deployment handle broke during use.¿ the following additional information was provided: ¿the stent was not out of the introducer when it broke.Staff squeezed the trigger 4-5 times then heard a snap.After the snap the trigger no longer functioned.There are no pictures but i am sending the stent in.¿ 1 x evo-22-27-6-d was returned to cirl for evaluation.Upon evaluation of the returned device, it was noted that there was no stent exposure on return and the lockwire was in place.The red safety tab was not returned.The red shuttle deployment marker was at the back of the handle.The handle was dismantled during lab evaluation and the flexor was seen to be broken at the shuttle cap.The stent was manually deployed during lab evaluation and no defects were noted with the stent.Complaint is confirmed as the failure was verified in the laboratory, the flexor was seen to be broken at the shuttle cap.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath the evo-22-27-6-d device of lot number c1367751 contains the component irs0052 (evo-22-27-6-d introducer no stent) of qc # (b)(4).A review of the records revealed no discrepancies that could have caused the complaint issue.Prior to distribution all evo-22-27-6-d devices are subject to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the evo-22-27-6-d device lot # revealed no discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue effects the entire lot #,upon review of complaints this failure mode has not occurred previously with this lot #.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided there were no adverse effects to the patient due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
Follow up mdr submitted due to: device return.The deployment handle broke during use.

• 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: 6921420
• Report Number: 3001845648-2017-00442
• Device Sequence Number: 819384
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)190615(10)C1367751
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/05/2017

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: 10/06/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1