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

Model Number G48038

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

During the procedure the stent is not working properly, the stent fails to deploy.No additional information received to date.

Manufacturer Narrative

Pma/510(k) #: k163468.

Event Description

Device evaluated on 25-jan-2021: "shuttle cap broken." no reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Report submitted as a cancellation report.

Event Description

Supplemental report being submitted due to additional information being received on 26-dec-2020.General questions: 1.At what stage of the procedure did the complaint occur? when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal 2.What endoscope type and channel size was used? 3.What was the position of the elevator? n/a, open, closed.4.Details of the wire guide used (diameter, type, make)? 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, no.6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, yes, no.7.Please advise the anatomical location of the intended target site.8.How long was the stent in the patient by the time this complaint occurred? 9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no.10.If yes, how often was this completed? 11.Did the patient require any additional procedures as a result of this event? n/a, yes, no.12.What intervention (if any) was required? 13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no 15.If yes, please specify what was observed and where on the device it was observed.Answer 1.During the stent placement.2.Olympus 190 series-4.2 mm channel diameter.3.Na.4.Cook -met-ii-35-480.5.Na.6.No.7.Sigmoid colon.8.Na.9.Na.10.Na.11.Yes.12.Deployed another evo-10-c.13.Same day.14.No.Stricture information: 1.What was the length and diameter of the stricture? 2.Where was the stricture located in the body? 3.Was there resistance felt passing wire guide through stricture? n/a, yes, no.4.Was there resistance felt passing the evolution through stricture? n/a, yes, no.5.Was the stricture dilated before stent placement? n/a yes, no.Answer 1.6 cm.2.Sigmoid colon.3.No.4.No.5.Yes.Questions related to during insertion into patient.1.Was the product inspected for kinks or damage before use? n/a, yes, no.2.Was resistance felt during insertion into patient? n/a, yes, no.3.If yes, at what point? answer 1.Yes , no kinks.2.No.3.No.Questions related to during stent placement 1.Did the product fail during stent deployment or recapture? n/a, deployment, recapture, other.2.If other, please specify.3.Was the directional button pressed during use? n/a, yes, no.4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, yes, no.5.Was the yellow marker kept in view during deployment? n/a, yes, no.6.Are images of the device or procedure available? n/a, yes, no].Answer 1.Deployment.2.Na.3.No.4.No.5.Yes.6.Yes (compliant stent is available ).Questions related to during introducer withdrawal 1.Are images of the device or procedure available? n/a, yes, no.2.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a, yes, no.3.If yes, what was used? 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a, yes, no.5.Was the safety wire fully removed before removing the delivery system? n/a, yes, no.6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, yes, no.Answer 1.Yes.2.Yes.3.Endoscopy & fluroscopy.4.Not able to trigger for deployment.5.Not deployed.6.No.Questions related to during stent repositioning/removal (for evo-fc & evo-pc devices) 1.What instrument was used for stent repositioning / removal? forceps, snare, other 2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? n/a, yes, no 4.If yes, please when this was felt? advancement or deployment 5.How did the physician deal with this resistance? 6.Was the lasso (suture) loop used during repositioning answer not able to deploy the stent , difficulty to trigger the stent during deployment.

Manufacturer Narrative

Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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
• MDR Report Key: 11054788
• MDR Text Key: 239276682
• Report Number: 3001845648-2020-00979
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)201212(10)C1568001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2020
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1568001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1