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

Model Number G48031

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

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

User advanced the device through wire guide to desired position, then pulled the safety wire after passing non-retrievable point.After implantation user retracted the delivery system from patient while found out the stent still stuck inside delivery system sheath.User changed another same device to complete the procedure.Device evaluated on 20-nov-2020."stent fully deployed.Lock wire was not returned".

Event Description

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

Manufacturer Narrative

Pma/510(k) #: k162717.Device evaluation: the evo-20-25-10-e device of lot number c1688438 involved in this complaint device was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 20th november 2020.In summary the following results were observed in the lab evaluation: stent was returned fully deployed and detached from the delivery system.Lock wire was not returned.Handle was actuating fine for deployment and recapture.As per image provided stent appears fully deployed on the delivery system tip.Documents review including ifu review: prior to distribution all evo-20-25-10-e 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-20-25-10-e device of lot number c1688438 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 #c1688438 ; upon review of complaints this failure mode has not occurred previously with this lot #c1688438.The instructions for use ifu0061-5 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If 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.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.There may be many possible root causes for the issue encountered, some may include the following: a possible root cause could be attributed to the difficult target site which could lead to a stent getting caught up on the delivery system tip, user technique or the suture getting caught up on the bi-lumen.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 10893851
• MDR Text Key: 251352868
• Report Number: 3001845648-2020-00887
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)211203(10)C1688438
• 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: 05/05/2021

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: 01/31/2023
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1688438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 61