MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48028

Device Problem Delivery System Failure (2905)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the evo-25-30-8-c device of lot number c1415953 was not returned to cook (b)(4) for evaluation.With the information provided a document based investigation was carried out.The following additional information was provided in the complaint file: there was no resistance encountered when advancing the wire guide through the stricture.There was no resistance encountered when advancing the introducer and stent into position.Olympus colonic endoscope olympus cfq-160-l endoscope was used during the procedure.Dilation of the stricture had not been performed prior to stent placement.No section of the device detach inside the patient.In addition the following additional information was received from the cook representative: was the stent deployed/ partially deployed? no.Did the physician hear any mechanical snapping, popping, or grinding coming from the handle? yes little.Did the physician notice any damage to the device? no, always check before use.Was there any intervention or any additional procedures?, no, use another evolution colonic stent.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Engineering input was obtained to determine the cause of this complaint, however as the device was not returned for investigation a definite root cause could not be determine.Possible cause of this event could have been a kink in the flexor, resulting in a buildup of pressure and the flexor breaking at the shuttle cap.Kink may have been patient anatomy related, i.E.Torturous patient anatomy, or on insertion into the scope.This would account for the users¿ inability to deploy the stent.Document review: prior to distribution all evo-25-30-8-c devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for this evolution device of lot c1415953 did not show any discrepancies in the manufacturing records that could have contributed to this complaint issue.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1415953; upon review of complaints this failure mode has not occurred previously with this lot # c1415953.Ifu review: 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 viable evidence to suggest that the user did not follow the instructions for use.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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

Malfunction of the handle, prosthesis couldn't be released."as per complaint form": the moment to operate the handle to release the stent this made noise, the stent was not released, remained inside the catheter.They checked the release button and it was correct.They proceeded to remove the system and use a new one.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• 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: 7361496
• MDR Text Key: 103415626
• Report Number: 3001845648-2018-00136
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)191101(10)C1415953
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2018
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1