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

Model Number G48028

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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

User detected the delivery system stuck while almost complete the stent releasing, and user cannot continue releas the stent and cannot retract the stent into delivery system.User retracted the endoscopy and delivery system while the stent detached and slip into obstruction area, and the sent drift between obstruction area and incisor.User placed another same stent at target area successfully.Patient is well few days after procedure as communicated with sales rep.Through phone call.Tom pan (b)(6) 2023 1.What is the reorder number of the wire guide used with this device? metii-35-480 - metii-35-480.2.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: 3.What is the endoscope manufacturer and model number that was used during the procedure? olympus 290 colonoscopy.4.Had dilation of the stricture been performed prior to stent placement?no.5.What was the diameter of the stricture at the time of stent placement (in mm)? 2 mm.6.What was the length of the stricture at the time of stent placement (in cm)? 3cm.7.Please describe the location in the body where the stent was to be placed.Colon transversum.8.Was resistance encountered when advancing the wire guide through the stricture? no.9.Was resistance encountered when advancing the introducer and stent into position? no.10.Did any section of the device detach inside the patient? yes.11.After placement, was stent position verified? if yes, please describe how.X ray.12.After placement, was the endoscope advanced through the stent? no.13.Please estimate amount of time the stent was in place prior to this occurrence.14.Did the patient undergo chemotherapy or radiation treatments after stent placement? not yet.Will do chemotherapy.

Event Description

This supplemental report is being submitted to include the lab re-evaluation and the completion of the investigation on the 07-jul-2023.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the evo-25-30-8-c device of lot number c1957041 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document-based investigation was conducted.The devices involved in the complaint were evaluated in the laboratory on the 28th feb 2023.The returned device lab findings and observations can be referred through the attached files.On evaluation of the devices the following was observed: visual inspection: safety wire and safety tab not returned.Directional button in deployment position.Red marker at first dimple.Damage noted on flexor at end of handle.No stent returned.Functional inspection: handle actuating fine for deployment and recapture.Manufacturing records: prior to distribution, all evo-25-30-8-c devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-25-30-8-c of lot number c1957041 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred with lot number c1957041.Instructions for use and/label: the notes section of the instructions for use, ifu0052, which accompanies this device instructs the user to inspect the device prior to use: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ there is no evidence to suggest that the customer did not follow the instructions for use.From additional information provided( q14.) patient may undergo chemotherapy treatment after stent placement."14.Did the patient undergo chemotherapy or radiation treatments after stent placement? not yet.Will do chemotherapy." ifu0052 instructs the user to 'after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.Therefore, a notification was sent to the product manager to consider retraining at the facility image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor (outer sheath) damage (kink) and causing issue reported.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, cannot release or retract stent and delivery system confirmed quantity of 01 device, confirmed used.According to the initial reporter, patient is well few days after procedure as communicated with sales rep.Through phone call.Investigation findings conclude that a possible root cause could be attributed to the torturous patient anatomy, causing a build-up of pressure and resulting in damaged flexor(outer sheath) and causing issue reported.Complaint is confirmed based on customer and/or rep testimony.

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16501611
• MDR Text Key: 311490136
• Report Number: 3001845648-2023-00158
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)240704(10)C1957041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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: Health Professional
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1957041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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