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

Catalog Number EVO-25-30-8-C

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k163468.(b)(4).The evo-25-30-8-c device of unknown lot number involved in this complaint was returned for evaluation, with the original packaging, however the label containing lot number was removed from the box.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 26 september 2018.On laboratory evaluation of the returned device, it was noted break in flexor at shuttle cap.Stent was not returned.Device not functioning.Old flexor design was noted.The break at the distal end of flexor (approx.148 mm from the blue to clear transition point) happened after the break at the shuttle cap.Following the laboratory evaluation and on further review of complaint it was noted by sustaining engineer that the evo-25-30-8-c device involved in this complaint was an old design.Therefore, additional information was requested to clarify the lot number complaint is confirmed as the failure was verified in the laboratory.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.It may be noted that a project has been assigned to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.Document review: prior to distribution all evo-25-30-8-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.The evo-25-30-8-c from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Lot number is currently unknown, as further clarification was required ifu review: the instructions for use ifu0052-10 which accompanies this device instructs the user to "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 ( ifu0052-10).Summary: complaint is confirmed as the failure was verified in the laboratory.The patient did not require any additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Stent couldn't be opened.New stent was used with worked correctly.Lot# given as c1295097, however this lot does not come up as ordered by the customer.Logged against the latest shipment with same rpn as per complaint form " problem statement customer: stent couldn't be opened.".Lot number confirmed as c1521417 device was evaluated on the 26-sep-2018: this file is being reported under the fda mdr malfunction precedence "flexor kinked/ stretched/ broke/ compressed".

• 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: 8000165
• MDR Text Key: 126237595
• Report Number: 3001845648-2018-00501
• Device Sequence Number: 1
• Product Code: MQR
• 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: Physician
• Type of Report: Initial
• Report Date: 09/26/2018

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 Catalogue Number: EVO-25-30-8-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2018
• 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