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 Off-Label Use (1494)

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

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k163468.(b)(4).The evo-25-30-6-c device of unknown lot number device involved in this complaint was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.A review of the manufacturing records could not be performed as the lot numbers for the devices used are unknown.Prior to distribution all evo devices are subjected to visual and functional inspection checks to ensure device integrity as per cook irl procedures.There is also a 100% visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.The instructions for use, ifu0052-10, that accompanies this device instructs the user to inspect the device prior to use : "if an 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 ( ifu0052-10).A definitive root cause can be attributed to user error as evo devices should not be used beyond the date specified on the product label, therefore the user did not follow the instructions for use.The customer complaint can be confirmed as the device was used after its expiry date.From the information provided, "the patient is doing well, for someone who has terminal cancer.There were no other issues, just the fact that the stent placed is expired." (ref.Att.'re pr262346 complaint form for completion').Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations, "this was simply an expired sems stent placement, the staff and dr.Did not check the expiration date and the stent was placed successfully.The stent expired in (b)(6) 2019".

• 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: 8652938
• MDR Text Key: 146515067
• Report Number: 3001845648-2019-00231
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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