MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-10-11-6-B

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

During an attempt to insert a stent in the biliary tract along the wire guide, the sheath of the introducer set was damaged.Which made it impossible, to expand and insert the stent.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.General questions: 1.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).Ad.1 during stent placement.2.What endoscope type and channel size was used? ad.2 duodenoscope olympus, v180 4.2 mm channel.3.What was the position of the elevator? was it opened or closed? ad.3 elevator was open.4.Details of the wire guide used (diameter, type, make)? ad.4 cook, medical, metii-35-480.5.Was the zip port facing upwards and slightly curved when backloading the wire guide? ad.5 yes.6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? ad.6 stent was inside of the biliary tract.7.Please advise the anatomical location of the intended target site.Ad.7 biliary tract.8.How long was the stent in the patient by the time this complaint occurred? ad.8 about 2 minutes.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? ad.9 yes.10.If yes, how often was this completed? ad.8 the intention was to place this stent for 6 month.11.Did the patient require any additional procedures as a result of this event? ad.11 no.12.What intervention (if any) was required? ad.12 another stent was used (evo).13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? ad.13 same procedure.14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? ad.14 no.15.If yes, please specify what was observed and where on the device it was observed? ad.15 n/a.Stricture information: 1.What was the length and diameter of the stricture? ad.1 stricture had about 3 cm.2.Where was the stricture located in the body? ad.2 biliary tract.3.Was there resistance felt passing wire guide through stricture? ad.3 there was no resistance.4.Was there resistance felt passing the evolution through stricture? ad.4 there was no resistance.5.Was the stricture dilated before stent placement? ad.5 no.Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? ad.1 yes.It was ok.2.Was resistance felt during insertion into patient? ad.2 there was no resistance.Questions related to during stent placement: 1.Did the product fail during stent deployment or recapture? ad.1 during stent deployment.2.Was the directional button pressed during use? ad.2 yes.3.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? ad.3 yes.4.Was the yellow marker kept in view during deployment? ad.4 yes.5.Are images of the device or procedure available? ad.5 no.Questions related to during introducer withdrawal: 1.Are images of the device or procedure available? ad.1 no.2.Was final stent placement confirmed using endoscopy / fluoroscopy? ad.2 stent placement was unsuccessful.3.If yes, what was used? ad.3 fluoroscopy was used.4.Did the stent open sufficiently to allow withdrawal of introducer safely? ad.4 did not open.5.Was the safety wire fully removed before removing the delivery system? ad.5 no.Stent was removed.6.Did any part of the product snag/get caught with the stent when removing the delivery system? ad.5 no.Questions related to during stent repositioning/removal (for evo-fc & evo-pc devices): 1.What instrument was used for stent repositioning / removal? forceps, snare, other.Ad.1 stent was removed by the working channel.2.If other, please specify? 3.Was resistance encountered during advancement and/or deployment? n/a, yes, no.Ad.3 yes.1.If yes, please when this was felt? advancement or deployment.Ad.1 advancement.2.How did the physician deal with this resistance? ad.2 he kept pressing the trigger.3.Was the lasso (suture) loop used during repositioning.Ad.3 no.

Event Description

Supplement report being submitted due to the completion of the investigation on 10-aug-2023.

Manufacturer Narrative

Device evaluation: the 1x evo-fc-10-11-6-b device of lot number c1999953 involved in this complaint was returned for evaluation, with its original opened packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on evaluation of the device, the following was observed: visual inspection: ¿ protective tubing in place upon return.¿ red safety tab not returned.¿ directional button in deployment position.¿ red marker at 13th dimple.¿ safety wire still in place.¿ flexor broken at approx.27cm from the white tip (at zip-port).Functional inspection: ¿ handle is actuating fine for deployment and recapture.¿ unable to deploy stent.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: there is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review: an image was not returned for evaluation.Root cause analysis: 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 torturous patient anatomy.As explained in the additional information received from the rep, there was resistance encountered during advancement and/or deployment.It is possible that during deployment tortuous path may have caused a kink in the flexor and continued attempts to deploy may have led to a build-up of pressure at the kink resulting in the flexor breaking.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Summary of investigation: as per the rep/customer testimony, during an attempt to insert a stent in the biliary tract along the wire guide, the sheath of the introducer set was damaged, which made it impossible to expand and insert the stent.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Confirmed quantity of 01 used device.The investigation findings concluded a possible root cause of torturous patient anatomy resulting in a kink in the flexor, and possible continued attempts to deployment could have resulted in a build up of pressure resulting in the flexor breaking at the kink site.Complaint is confirmed based on visual and/or functional inspection.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.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16910425
• MDR Text Key: 315000409
• Report Number: 3001845648-2023-00344
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)241110(10)C1999953
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-10-11-6-B
• Device Lot Number: C1999953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2023
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1