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 Failure of Implant (1924)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

510(k) number: k163468.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User advanced the delivery system through wire guide to desired stenosis area.User placed the delivery system at 3-4cm front of stenosis area and ready to release the stent.User pulled the trigger each time and the sheath backed a little, and meanwhile the yellow marker on the stent always stays at 3-4 cm front of stenosis.User saw the tip of the stent open through x-ray, but the stent suddenly move forward and detached from sheath while user release the stent in half.The yellow marker on the tip of stent still remains at 3-4cm front of stenosis, user cannot retract the stent by pressing the retracting trigger.User saw the whole stent squeeze in 4cm long 4cm in front of stenosis area.User left the stent in patient colon and placed another stent at stenosis area with no issue.

Manufacturer Narrative

510(k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113 the evo-25-30-10-c device of lot number c1556613 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory on 01st may 2019.Outer sheath was observed kinked.Therefore following the laboratory evaluation additional information was requested to clarify if there was a kink observed when the device were being sent back to cook ireland.As per additional information received: was there a kinked flexor observed when the device were being sent back to cook ireland? no.Following the laboratory evaluation additional information was requested to aid with the investigation: why did they try to retract the stent if the stent was placed in the correct position? because the whole stent off from delivery system by itself while user was in the middle of releasing stent.The stent was not positioned in correct position.Are images of the devices or procedure available? under collection.When did they removed the lock wire? for safety reasons, user complete the releasing procedure include lock wire removal because the stent was off from delivery system unexpectedly.When "the user saw the whole stent squeeze in 4 cm long 4cm in front of stenosis area "was the delivery system outside the patient? the delivery system was outside of patient at the moment the user saw the whole stent squeeze in 4 cm long 4cm in front of stenosis area through x-ray."the user saw the whole stent squeeze in 4 cm long 4cm in front of stenosis area " does this mean the stent was squeezed down to 4cm length with 4cm diameter? ¿in front of stenosis¿ the stent was squeezed down to 4cm long in front of stenosis area.The stent was placed 4 cm in front of stenosis.(no diameter provided regarding the stent).Was it distal or proximal to stenosis? distal.Did the stent partially covered the stenosis or the stent was completely outside the stenosis? outside the stenosis.As per additional information received "dealer confirmed there is no image available for the complaint." prior to distribution all evo-25-30-10-cdevices 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 manufacturing records for evo-25-30-10-c device of lot number c1556613 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot # c1556613, upon review of complaints this failure mode has not occurred previously with this lot # c1556613.The instructions for use ifu0052-10 which accompanies this device instructs the user to "when sent point-of no return has passed, pull safety wire out of delivery handle near wire guide port" there is no evidence to suggest that the customer did not follow the instructions for use ifu0052-10.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause for the difficulties experienced may be related to tortuous anatomy according to the initial reporter, the stent remains in patient's colon at front of the stenosis.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

User advanced the delivery system through wire guide to desired stenosis area.User placed the delivery system at 3-4cm front of stenosis area and ready to release the stent.User pulled the trigger each time and the sheath backed a little, and meanwhile the yellow marker on the stent always stays at 3-4 cm front of stenosis.User saw the tip of the stent open through x-ray, but the stent suddenly move forward and detached from sheath while user release the stent in half.The yellow marker on the tip of stent still remains at 3-4cm front of stenosis, user cannot retract the stent by pressing the retracting trigger.User saw the whole stent squeeze in 4cm long 4cm in front of stenosis area.User left the stent in patient colon and placed another stent at stenosis area with no issue.

Manufacturer Narrative

510(k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User advanced the delivery system through wire guide to desired stenosis area.User placed the delivery system at 3-4cm front of stenosis area and ready to release the stent.User pulled the trigger each time and the sheath backed a little, and meanwhile the yellow marker on the stent always stays at 3-4 cm front of stenosis.User saw the tip of the stent open through x-ray, but the stent suddenly move forward and detached from sheath while user release the stent in half.The yellow marker on the tip of stent still remains at 3-4cm front of stenosis, user cannot retract the stent by pressing the retracting trigger.User saw the whole stent squeeze in 4cm long 4cm in front of stenosis area.User left the stent in patient colon and placed another stent at stenosis area with no issue.

• 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: 8577446
• MDR Text Key: 143949768
• Report Number: 3001845648-2019-00191
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)201109(10)C1556613
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2020
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1556613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 46