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

Model Number	G23129
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
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
The fully covered biliary prosthesis was introduced, and positioned according to the stenosis, but there was no release of the safety lock.The safety wire showed a lot of resistance, breaking (released the red part of the wire).After the prosthesis was released, when removing the introducer, the prosthesis came out together.To finish the procedure, a prosthesis of another size (6 cm) was placed, which was properly positioned.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.In the photos provided, some of the wires on the stent appear to be distorted, could you please confirm if this is correct? no, it stayed the way it was, dr.Withdrew it very carefully because he knew the prosthesis could come with it.If so, was there any injury/adverse effect experienced by the patient, or additional procedures/intervention required due to this? n/a.The stent is fully deployed in the photos provided, can you confirm that this is how it was removed from the patient? i.E.It was not possible to recapture the stent and the exposed stent was removed with the delivery system? exactly, the dr.Totally released the prosthesis and had no way to recapture.Did the red plastic covering on the safety wire at the back of the delivery handle, come off the handle but not the internal mechanisms which allow for removal of the safety wire? yes, the plastic cover came off the wire, but not the internal mechanisms.In addition to the above, could you also answer the below standard evo questions please: was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? yes, it did, and when it was just before the no return area the doctor tried to release the safety thread without success.Did the red indicator continue to move after the delivery stopped? yes.Were any cracking/popping sounds heard from the handle? no.Were any additional procedures needed? no, the dr.Just had to put another prosthesis as it was initially programmed.What is the patient outcome? dr used another prosthesis that was available.Patient did not get worse due to the problem in the material.Prefix: evo.General questions: at what stage of the procedure did the complaint occur?(when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal) - when removing the safety wire.What endoscope type and channel size was used? olympus - tj-160.What was the position of the elevator? was it opened or closed? n/a.Details of the wire guide used (diameter, type, make)? metii-35-4800.Did any part of the stent contact the patient's anatomy when the complaint occurred? yes, he was releasing the prosthesis.How long was the stent in the patient by the time this complaint occurred? only during the prosthesis positioning time.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? n/a.Is the patient known to be covid-19 positive? no.Stricture information: what was the length and diameter of the stricture? not informed.Where was the stricture located in the body? bile duct.Was there resistance felt passing wire guide through stricture? no.Was there resistance felt passing the evolution through stricture? not informed.Was the stricture dilated before stent placement? not informed.Questions related to during insertion into patient: was the product inspected for kinks or damage before use? yes.Was resistance felt during insertion into patient? if yes, at what point? no.Questions related to during stent placement: did the product fail during stent deployment or recapture? stent deployment.Was the directional button pressed during use? at the beginning.Was any part of the stent observed in contact with the patient's anatomy at the time of failure? the stent was already released in the correct position.Was the yellow marker kept in view during deployment? yes.Are images of the device or procedure available? yes.Questions related to during introducer withdrawal: was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? it was confirmed by endoscopy.Did the stent open sufficiently to allow withdrawal of introducer safely? yes, it was already in a position of no return.Was the safety wire fully removed before removing the delivery system? no, the safety wire was stuck in the prosthesis, causing the problem.Did any part of the product snag/get caught with the stent when removing the delivery system? the safety wire.Are images of the device or procedure available? yes.Questions related to during stent repositioning/removal: what instrument was used for stent repositioning / removal? forceps, snare.Was the lasso (suture) loop used during repositioning: none.
Additional Manufacturer Narrative
Component code (annex g): g07001 - part/component/sub-assembly term not applicable.Lab evaluation: the evo-10-11-8-b device of lot number c1599192 involved in this complaint device was not returned for evaluation.With the information provided, a document based investigation was conducted.From the images provided, stent appears to be fully deployed and attached to the lock wire and the lock wire mlla appears to be broken.Some of the wires on the stent appear to be distorted (ref.Att."pr 307890 fw rpnc 1065-df.Msg ( source doc, cc form and pictures).Msg").Documents review including ifu review: prior to distribution all evo-10-11-8-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-10-11-8-b device of lot number c1599192 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 # c1599192 ; upon review of complaints this failure mode has not occurred previously with this lot #c1599192.The instructions for use ifu0056-5 which accompanies this device instructs the user to "when stent point -of -no return has been passed, disconnect luer lock fitting and remove safety wire completely from delivery handle." there is evidence to suggest that the customer did not follow the instructions for use.From additional information provided, " when during procedure they try to pull the lock wire? when the marker was in the white sector, before the no return part.The doctor made the scope, saw that it was the ideal position and tried to remove the safety wire, at this moment the wire did not come out and broke the red part.The doctor finished removing the prosthesis in an attempt to keep it in position, which did not happen, the prosthesis came together when the doctor went to remove the catheter." root cause review: a definitive root cause could be determined from the available information.A definitive root cause could be attributed to the user error, from additional information provided the release of the safety wire occurred before the point of no return.It is possible that this resulted in no release of the safety wire and it caused the resistance which led to lock wire mlla breakage.It may be noted that some of the wires on the stent were pictured out of shape, however this is likely due to removal.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• 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: 10582858
• Report Number: 3001845648-2020-00654
• Device Sequence Number: 19610431
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)210327(10)C1599192
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 03/27/2021
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1599192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR