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

Catalog Number EVO-25-30-6-C

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

The delivery system was returned for evaluation with the stent deployed and no stent was returned with the device.On evaluation of the returned device, it was observed that the handle was opened at the proximal end of the handle.The polyimide to peak joint was broken and the handle had actuated ok.The handle assembly was dismantled during the evaluation by the cirl research and development engineer and it was evident that there was two kink marks on the flexor.The first kink was from the front end of the cap at 155mm and the second kink at 182mm.The flexor seems ok as there was no roughness or stretching noted.Additional queries have been sent in relation to the complaint ¿was there any resistance felt when removing the device, endoscopic or fluoroscopic images of the stent." a response has not been received.The stent deployment indicator was not fully back, which contradicts what the complaint report suggests.If this is the point where they started removing the delivery system, the stent would be still connected and it would explain why the stent ended up inside the scope.They should have verified stent deployment fluoroscopically.According to the description ¿they thought to have it deployed 100%.Handle indicator was completely at the end.¿ based on photos from the lab evaluation and senior production manager input ¿if this is the point where they started removing the delivery system, the stent would be still connected and it would explain why the stent ended up inside the scope." the customer complaint could not be confirmed as the stent deployment indicator on the returned device was not in the fully deployed position as stated in complaint description and also no images were received.Prior to distribution all evolution devices are subject to visual inspection and functional checks to ensure device integrity as per cirl procedures.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.The instructions for use, for evolution colonic stent system ¿ uncovered advises the user ¿to ensure that stent will bridge stricture after deployment, fluoroscopically position radiopaque markers on inner catheter beyond extremities of stricture to be crossed.Note: yellow marker on the delivery system located at proximal end of stent can also serve as a endoscopic/ fluoroscopic reference for positioning of the proximal (nearest user) end of the stent relative to the stricture.¿ the instructions for use, step 10: when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.Step 11: continue deploying stent by squeezing trigger.Step 12: after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed.From the information provided, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The user thought they deployed an evolution colonic stent 100%.Handle indicator was completely at the end but the stent was not visible on x ray.Device was removed but the stent was not in the introduction system.The evolution colonic stent was stuck in the accessory channel of the scope.Fda mdr reporting required based on a malfunction reporting precedence established for this device family.

• 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: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5646708
• MDR Text Key: 44986956
• Report Number: 3001845648-2016-00123
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480299
• UDI-Public: (01)10827002480299(17)171020(10)C1162477
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113510
• 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: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-25-30-6-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2016
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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