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

Model Number G48026

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User advanced the device to desired position and press the trigger to start releasing the stent, but there is no sign of stent under endoscopy after the stent deployment completed.User retracted the device and checked while found out the stent is still inside the sheath and cannot release.User changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k)#: k163468 lab evaluation completed on (b)(6) 2020, a follow up mdr will be submitted to include the investigation conclusions once completed.

Event Description

User advanced the device to desired position and press the trigger to start releasing the stent, but there is no sign of stent under endoscopy after the stent deployment completed.User retracted the device and checked while found out the stent is still inside the sheath and cannot release.User changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k)#: k163468.This report is being submitted as a cancellation report.This file has been reassessed as not reportable following completion of the investigation on 29 june 2020.During the lab evaluation it was noted that the shuttle cap was broken which is categorized as low risk.This will remove the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed' which this report was initially submitted on.In addition no injury to the patient has occurred.Device evaluation: the evo-22-27-9-d device of lot number c1542325 involved in this complaint device involved was returned for evaluation, without 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 the 22nd april 2020.The returned device lab findings and observations can be referred through the attached files.In summary the following results were observed in the lab evaluation: handle was actuating fine, however unable to deploy the stent.Handle was opened and shuttle cap was found to be broken.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 lot number c1542325did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1542325; upon review of complaints this failure mode has not occurred previously with this lot #c1542325.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.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 could be attributed to material failure.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

This report is being submitted as a cancellation report.This file has been reassessed as not reportable following completion of the investigation on 29 june 2020.During the lab evaluation it was noted that the shuttle cap was broken which is categorized as low risk.This will remove the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed' which this report was initially submitted on.In addition no injury to the patient has occurred.

• 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: 9957228
• MDR Text Key: 221544447
• Report Number: 3001845648-2020-00242
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)200921(10)C1542325
• 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,Followup
• Report Date: 06/29/2020

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: 09/21/2020
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1542325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 03/18/2020; 03/18/2020
• Supplement Dates FDA Received: 05/13/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR