MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48026

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)

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

Event Date 12/07/2019

Event Type  malfunction  

Manufacturer Narrative

K163468 - us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The stricture was in duodenum d-2 region and the length was measured around 4 cm.The stent jump off within twice the triger pressed after releasing the stylet which results in the inaccurate position to cover the stricture.Managed to complete the procedure by deploying other company stents.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue resulting in stent deployed in incorrect location¿.No adverse effects to the patient have been reported as occurring.

Event Description

The stricture was in duodenum d-2 region and the length was measured around 4 cm.The stent jump off within twice the trigger pressed after releasing the stylet which results in the inaccurate position to cover the stricture.Managed to complete the procedure by deploying other company stents.

Manufacturer Narrative

Pma/510(k)#: k163468.Device evaluation: the evo-22-27-9-d device of lot number (b)(6) involved in this complaint device was not returned for evaluation.With the information provided document based investigation was conducted.Additional information was requested to aid with this investigation.However, the relevant information has not yet been provided, therefore, if it is received, the file will be updated accordingly.Documents review including ifu review: prior to distribution all evo-22-27-9-d 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-22-27-9-d device of (b)(6) lot number 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 #(b)(6); upon review of complaints this failure mode has not occurred previously with this lot #(b)(6).The instructions for use ifu0053-9 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 ifu0053-9.Root cause review: a definitive root cause could not be determined from the available information.A tortuous anatomy may have compressed the introducer resulting in stent deployment in an incorrect location.However, as the device was not returned for evaluation; and due to limited information available the cause of this complaint could not be conclusively determined.Summary: according to the initial reporter, the patient required an additional stent.Customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9537590
• MDR Text Key: 220635728
• Report Number: 3001845648-2019-00788
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)201218(10)C1570308
• 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
• Report Date: 03/12/2020

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: 12/18/2020
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1570308
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 56