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

Model Number G48026

Device Problem Delivery System Failure (2905)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468".(b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".After the doctor place the whole system into the duodenal , they try to withdraw the stent from the handle, but they hear a sound from the handle then they cannot withdraw the stent, so they use another new device.

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468".(b)(4).Exemption number: e2016031.(b)(4).Problem statement: the customer reported the following complaint issue: ¿after a sound from the handle then physician cannot withdraw the stent¿ ¿after the doctor place the whole system into the duodenal, they try to withdraw the stent from the handle, but they hear a sound from the handle then they cannot withdraw the stent, so they use another new device.¿ device evaluation: the evo-22-27-9-d device of lot number c1213228 was returned to cook ireland and evaluated on the 08-dec-2018.Lab evaluation: upon evaluation of the returned device, it was noted that there was no stent exposure.No lock wire was returned.The red shuttle deployment marker was at the back of the handle.Actuation for deployment or retraction was not possible.The handle of the device 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 with no difficulty and the stent was seen to be fine.The customer complaint confirmed as failure was verified in laboratory.The customer complaint was confirmed as the flexor was seen to be broken at the shuttle cap during lab evaluation.It may be noted that the following additional information was also received from the cook representative: " was the delivery system removed with the stent partially deployed? no.Was the directional button fully engaged during deployment? yes.Did the patient require any additional procedures or intervention due to this incident? no".Root cause: a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.Documents review: prior to distribution all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.As per fqc: ¿inspect for visual defects; i.E.Loose or embedded foreign materials, rough or sharp edges, kinks.¿ ¿ensure that there are no sharp edges or damage to the sheath tip area." ifu review: as per the instructions for use, which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Summary: customer complaint confirmed as failure was verified in laboratory.The customer complaint was confirmed as the flexor was seen to be broken at the shuttle cap during lab evaluation.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Follow up mdr is being submitted to update the investigation conclusions.Mdr submitted based on the device malfunction precedence: ¿flexor kinked/ stretched/ broke/ compressed".After the doctor place the whole system into the duodenal , they try to withdraw the stent from the handle, but they hear a sound from the handle then they cannot withdraw the stent, so they use another new device.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7153794
• MDR Text Key: 96344802
• Report Number: 3001845648-2017-00610
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)180318(10)C1213228
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

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
• Device Operator: No Information
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/29/2017
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 56