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

Model Number	G48028
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional 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.This complaint is linked to another file (b)(4) 3001845648-2019-00021 (broken flexor) as a second failure - kinked flexor was observed during the lab evaluation.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 30th january 2019.Flexor was observed kinked.Documents review including ifu 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.A review of the manufacturing records for evo-25-30-8-c device of lot number c1311877 did not reveal any discrepancies that could have contributed to this issue.Upon review of complaints, this failure mode has occurred previously with lot number c1311877.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1311877.This complaint is linked to complaint file (b)(4) (broken flexor) as a second failure - kinked flexor was observed during the lab evaluation.A project was carried out to make improvements to the flexor design.The instructions for use ifu0052-10 which accompanies this device and instructs the user to ""visually inspect with particular attention to kinks, bends and breaks.If any 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.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause of kinked flexor could be attributed to transport returns.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 or Problem Description
Flexor kinked observed during lab evaluation.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8373358
• Report Number: 3001845648-2019-00078
• Device Sequence Number: 2371080
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190106(10)C1311877
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2019
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1311877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1