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 Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #; k163468.Device evaluation: the evo-25-30-10-c device of lot number c1579415 involved in this complaint device involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 10th october 2019.Flexor was found to be broken.The flexor was seen to be broken at the handle.It was also seen to be twisted and deformed at this point.Documents review including ifu review: prior to distribution all evo-25-30-10-c devices 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 c1579415 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 #c1579415; upon review of complaints this failure mode has not occurred previously with this lot #c1579415.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is evidence to suggest that the customer did not follow the instructions for use.From the information provided the product was not inspected for kinks or damage before use.Image review: n/a.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.There may be several possible root causes for the break in the flexor, it may be as a result of handling removing the device from packaging or during preparation, it may be down to transport/storage or it may be due to patient anatomy.As the user informs us that they failed to check the device for damage prior to use, this failure to follow the instructions for use must be taken into account.It is possible that there have been damage to the flexor present prior to use, possibly due to handling of the device prior to use and as the device was not inspected went unnoticed.If the device had been used damaged it may have then led to the break in the flexor due to a build-up in pressure.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As initially reported to customer relations via verbal conversation: a patient underwent a colonoscopy in which qty.1 of the evolution colonic controlled-release stent-uncovered, g48038, was used.The physician was attempting to deploy the stent but noted it was hard to squeeze the trigger and that something had popped.The device was removed and noted that the stent had never exited the catheter.Another of the same device only in an 8cm size was used to continue the procedure with on further complications.

• 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: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9186019
• MDR Text Key: 219385815
• Report Number: 3001845648-2019-00521
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)210124(10)C1579415
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/16/2019

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 Expiration Date: 01/24/2021
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1579415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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