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

Model Number	G23129
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The approach was gained from oral, targeting the common bile duct.The patient had jaundice.On (b)(6), the reported stent was placed in the middle bile duct.After the placement, the stent could not be fully expanded.(50% of full expansion)/the stent remain partially constrained after placement, though jaundice decreased (improved).On (b)(6) 2020, due to the increase of jaundice, it was confirmed by abdominal x-ray that the reported stent have migrated to the upper bile duct.((b)(4)) it is a situation that the reported stent is not placed in the stenosis part.On (b)(6), since drainage became impossible, evo-10-11-8-b was placed from the middle of the reported stent out to the duodenal papilla by using stent-in-stent technique as a retreatment((b)(4)).Due to the retreatment, hospitalization became extended.After the retreatment, jaundice decreased (improved), but the patient has developed retrograde cholangitis (this report).Retrograde cholangitis has been treated, and as of (b)(6) 2020, the patient is improving/getting better and the patient will undergo chemotherapy soon.Patient outcome: jaundice decreased (improved), but the patient has developed retrograde cholangitis.Retrograde cholangitis has been treated, and as of (b)(6) 2020, the patient is improving/getting better and the patient will undergo chemotherapy soon.
Additional Manufacturer Narrative
This is a cancellation report.As per clinical input received on 09-dec-2020 'yes, the stent migrated out of the obstructed area, which was the reason another stent was placed.The obstruction due to stent migration could cause jaundice and/or retrograde cholangitis.¿ as all events are cascading.Therefore current mdr no longer required as pr 310190 (emdr 3001845648-2020-00805) will capture stent migration, jaundice and cholangitis.
Event or Problem Description
This is a cancellation report.As per clinical input received on (b)(6) 2020 'yes, the stent migrated out of the obstructed area, which was the reason another stent was placed.The obstruction due to stent migration could cause jaundice and/or retrograde cholangitis.¿ as all events are cascading.Therefore current mdr no longer required as pr 310190 (emdr 3001845648-2020-00805) will capture stent migration, jaundice and cholangitis.
Event or Problem Description
Supplemental report required to revoke previously submitted cancellation report.Clinical input received 12-jan-2021."only if there was no detailed or further information, medical affairs will presume the most likely scenarios based on the medical/clinical knowledge.However, if physician had provided their thoughts or opinion or possible reason in relation to the adverse event.We would normally take physician¿s feedback as they are the experts in the field who had the best knowledge of what and how the procedure being performed.Therefore, in this case if the physician thinks the retrograde cholangitis was caused by using stent-in-stent technique, we should take it as the root of cause." (b)(4) will remain opened to capture retrograde cholangitis as a procedure related (stent-in-stent) complication.The approach was gained from oral, targeting the common bile duct.The patient had jaundice.On september 3rd, the reported stent was placed in the middle bile duct.After the placement, the stent could not be fully expanded.(50% of full expansion)/the stent remain partially constrained after placement, though jaundice decreased (improved).On (b)(6) 2020, due to the increase of jaundice, it was confirmed by abdominal x-ray that the reported stent have migrated to the upper bile duct.((b)(4)) it is a situation that the reported stent is not placed in the stenosis part.On september 24th, since drainage became impossible, evo-10-11-8-b was placed from the middle of the reported stent out to the duodenal papilla by using stent-in-stent technique as a retreatment(cook ref (b)(4)).Due to the retreatment, hospitalization became extended.After the retreatment, jaundice decreased (improved), but the patient has developed retrograde cholangitis (this report).Retrograde cholangitis has been treated, and as of 10/20, the patient is improving/getting better and the patient will undergo chemotherapy soon.Patient outcome: jaundice decreased (improved), but the patient has developed retrograde cholangitis.Retrograde cholangitis has been treated, and as of 10/20, the patient is improving/getting better and the patient will undergo chemotherapy soon.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
This file is related to complaint file (b)(4) ¿stent migration¿.3001845648-2020-00805 device evaluation: the device evaluation could not be completed as the evo-10-11-8-b device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1688879 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label: as per the instructions for use, ifu0056 which informs the user that '' potential complications associated with ercp include, but are not limited to; pancreatitis, cholangitis , cholecystitis, cholestasis aspiration, perforation ,haemorrhage ,infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.The ifu also states "in the event a single stent will not adequately cover the stricture, a second stent of the same diameter should be placed providing adequate overlapping (minimum 1cm) of the initially placed stent to ensure a bridging of the stricture between the stents." there is no evidence to suggest that the customer did not follow the instructions for use.The japanese packaging insert c-es1607y02 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause analysis: a definitive root cause could not be determined from the available information.As per additional information provided ¿regarding retrograde cholangitis, the physician thinks placing evo-10-11-8-b (the second stent of the retreatment)from the middle of the reported stent ((b)(4) the first stent) by using stent-in-stent technique is a cause.¿ additionally a possible root cause could be attributed to patient condition related, as per instructions for use, cholangitis is listed as a complication following the placement of this device.Summary of investigation: according to the customer the patient developed retrograde cholangitis confirmed quantity of 1 device, confirmed used.According to the initial report, the retrograde cholangitis has been treated.Investigation findings conclude a possible root cause regarding retrograde cholangitis, the physician thinks placing evo-10-11-8-b (the second stent of the retreatment)from the middle of the reported stent ((b)(4) the first stent) by using stent-in-stent technique is a cause.¿ complaint confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to completion of the investigation on 13oct2022.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 10849886
• Report Number: 3001845648-2020-00872
• Device Sequence Number: 19078249
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)211204(10)C1688879
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1688879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 10/20/2020; 10/20/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/16/2020; 02/10/2021; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown