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

Model Number G48033

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

During the endoscopy procedure for the insertion of an esophageal prosthesis, the responsible physician positioned the prosthesis for release and, when the correct release was achieved, removed the mandrel for the stent release.However, the prosthesis was attached to the introducer.The doctor removed the introducer and the prosthesis came with it.After a few attempts, the doctor removed the whole set and the prosthesis joined, passed another prosthesis and there was no problem with this one.As the procedure was performed in the operating room, it was not possible to register using photos.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.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).After stent placement.It was not possible to release the stent into the patient.What endoscope type and channel size was used? the product was not passed through the device, the stent is released sideways to the device, as it is not possible to transpose the device due to the diameter.What was the position of the elevator? was it opened or closed? n/a.Details of the wire guide used (diameter, type, make)? gilliard- savary guide wire used.Did any part of the stent contact the patient's anatomy when the complaint occurred? yes.Esophagus.How long was the stent in the patient by the time this complaint occurred? about 5 minutes, the stent was released and when it was not possible, the stent was replaced by another.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? yes.Stricture information: what was the length and diameter of the stricture? 8 cm lesion with partial impairment of esophageal circumference.Where was the stricture located in the body? esophagus.Was there resistance felt passing wire guide through stricture? no, there wasn¿t.Was there resistance felt passing the evolution through stricture? no, there wasn¿t.Was the stricture dilated before stent placement? no, it wasn¿t.Questions related to during insertion into patient was the product inspected for kinks or damage before use? yes, it did.Was resistance felt during insertion into patient? if yes, at what point? no, it didn¿t.Questions related to during stent placement did the product fail during stent deployment or recapture? during stent release.Was the directional button pressed during use? yes, to reposition the stent before release.Was any part of the stent observed in contact with the patient's anatomy at the time of failure? yes.Esophagus.Was the yellow marker kept in view during deployment? n/a.Are images of the device or procedure available? no, there aren¿t.Questions related to during introducer withdrawal was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? yes.Fluoroscopy.Did the stent open sufficiently to allow withdrawal of introducer safely? yes, it did.Was the safety wire fully removed before removing the delivery system? yes, it was.Did any part of the product snag/get caught with the stent when removing the delivery system? yes, the stent was attached to the stent introducer.Are images of the device or procedure available? no, there aren¿t.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.It was the lasso loop (suture) used during repositioning.

Manufacturer Narrative

Pma/510(k) #: k162717.Device evaluation: the evo-20-25-15-e device of lot number c1545283 involved in this complaint was not returned for evaluation.With the information provided a document based investigation was conducted.Lab evaluation: n/a.Documents review including ifu review: prior to distribution all evo-20-25-15-e devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-15-e device of lot number c1545283 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 #c1545283; upon review of complaints this failure mode has not occurred previously with this lot #c1545283.As per the instructions for use, ifu0061-5, notes section the user is instructed of the following: "if stent repositioning is required during deployment, it is possible to recapture stent.Note: it is not possible to recapture stent after passing point-of-no-return, indicated when red marker on top of introducer has passed the point-of-no-return indicator on handle." there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed the difficult target site which could lead to a stent getting caught up on the delivery system tip.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: complaint is confirmed based on the customer¿s 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 Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11812799
• MDR Text Key: 281513540
• Report Number: 3001845648-2021-00384
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)201002(10)C1545283
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1545283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR