MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23127
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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
They had an issue with their evolution biliary stent g23127 lot c1588832.During an ercp with dr.(b)(6), the evolution biliary stent would not deploy.The procedure continued by another stent and completed.Procedure date unknown.
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
They had an issue with their evolution biliary stent g23127 lot c1588832.During an ercp with dr.(b)(6), the evolution biliary stent would not deploy.The procedure continued by another stent and completed.Procedure date unknown.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.No adverse effects to the patient have been reported as occurring.
Event or Problem Description
They had an issue with their evolution biliary stent g23127 lot c1588832.During an ercp with dr.Kyanam, the evolution biliary stent would not deploy.The procedure continued by another stent and completed.Procedure date unknown.
Additional Manufacturer Narrative
Device evaluation: the evo-10-11-4-b device of lot number c1588832 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.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 02nd december 2019.The returned devices lab findings and observations can be referred through the attached files.Stent was partially deployed on return however there was no defect found in the laboratory, devices functioned as intended.Safety wire was not returned.Handle was actuating fine and stent fully deployed without any issues.Stent was observed intact.Documents review including ifu review: prior to distribution all evo-10-11-4-b 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-10-11-4-b device of lot number c1588832 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 #c1588832; upon review of complaints this failure mode has not occurred previously with this lot #c1588832.The instructions for use ifu0056-5 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 ifu0056-5.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 potentially to patient anatomy as the device when returned for evaluation functioned as intended.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Follow up report is being submitted to update the reason for reporting in the complaint description which has changed since the last report.They had an issue with their evolution biliary stent g23127 lot c1588832.During an ercp with dr.(b)(6), the evolution biliary stent would not deploy.The procedure continued by another stent and completed.Procedure date unknown.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 that results in exposed stent removed from patient with delivery system'.No adverse effects to the patient have been reported as occurring.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9350997
• Report Number: 3001845648-2019-00618
• Device Sequence Number: 16490027
• Product Code: FGE
• UDI-Device Identifier: 10827002231273
• UDI-Public: (01)10827002231273(17)210222(10)C1588832
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121430
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: G23127
• Device Catalogue Number: EVO-10-11-4-B
• Device Lot Number: C1588832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 10/31/2019; 10/31/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/19/2019; 01/17/2020; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1