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

Model Number	G48027
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User advanced the device through wire guide to desired position and detected the stent cannot be released from delivery system, and then user pulled out the safety wire and still cannot release the stent.User then changed with a similar device from microtech to finish the procedure.
Additional Manufacturer Narrative
Pma/510(k)#: k163468.The evo-22-27-12-d device of lot number c1573543 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory.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.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.Prior to distribution all evo-22-27-12-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-22-27-12-d device of lot number c1573543 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 #c1573543; upon review of complaints this failure mode has not occurred previously with this lot #c1573543.The instructions for use 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.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.
Event or Problem Description
User advanced the device through wire guide to desired position and detected the stent cannot be released from delivery system, and then user pulled out the safety wire and still cannot release the stent.User then changed with a similar device from microtech to finish the procedure.
Event or Problem Description
User advanced the device through wire guide to desired position and detected the stent cannot be released from delivery system, and then user pulled out the safety wire and still cannot release the stent.User then changed with a similar device from (b)(4) to finish the procedure.
Additional Manufacturer Narrative
Pma/510(k)#: k163468.Lab evaluation completed on 08apr2020 and the investigation is pending.
Event or Problem Description
Correction report being submitted, complaint was reassessed as not reportable following lab evaluation on 08apr2020, complete report submitted on (b)(6) 2020 should have been a cancellation report.Lab evaluation details remove the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed'.Issue of shuttle cap is low risk and no adverse effects to the patient were reported.
Additional Manufacturer Narrative
Pma/510(k)#: k163468.Correction report being submitted, complaint was reassessed as not reportable following lab evaluation on 08apr2020, complete report submitted on (b)(6) 2020 should have been a cancellation report.Lab evaluation details remove the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed'.Issue of shuttle cap is low risk and no adverse effects to the patient were reported.The evo-22-27-12-d device of lot number c1573543 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory.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.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.Prior to distribution all evo-22-27-12-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-22-27-12-d device of lot number c1573543 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 #c1573543; upon review of complaints this failure mode has not occurred previously with this lot #c1573543.The instructions for use 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.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.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9928910
• Report Number: 3001845648-2020-00198
• Device Sequence Number: 16851041
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)210109(10)C1573543
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2021

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: 01/09/2021
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1573543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 03/09/2020; 03/09/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/05/2020; 06/26/2020; 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR