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

Model Number G48031

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Paediatric olympus gastroscope passed beyond the stricture and placed savary guidewire and external markers placed using fluoroscope.Over the pre-positioned guidewire ,passed the 10 cm partially covered evolution oesophageal delivery device after flushing the guidewire port with distilled water and lubricated with xylocaine jelly for smooth passage of delivery and crossed beyond the stricture and tried to deploy the stent.After three squeezes the triggering was very difficult to squeeze,tried to recapture ,positioned back to original position and again pressed the deployment button and tried to deploy ,three squeezes went well again felt harder to deploy ,the styles tried to came out of the uppper part of the handle ,removed delivery device from the patients body,tried outside to deploy ,very difficult to squeeze,found malfunction of handle,not able to deploy the 10cm stent.Immediately taken 12.5cm evolution stent and completed the procedure successfully.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to device evaluation on 09-dec-2021.

Manufacturer Narrative

Pma/510(k) #: (b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

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

Manufacturer Narrative

Pma/510(k) #: k162717.Device evaluation 1 unit of evo-20-25-10-e and lot# c1835379 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.  lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 09 dec 2021.On evaluation of the device it was observed there was 2 kinks approximately 37cm and 40cm from the tip.Stent was partially deployed on return.Safety wire was partially removed on return.Handle was actuating fine for deployment and recapture.Stent was fully deployed.Unable to remove the lock wire.Following the lab evaluation additional information was requested to aid with this investigation: were the kinks observed on the device prior to return? proximal end of the stent ,over the catheter.Was there resistance felt passing the evolution through stricture? no.How did the physician deal with this resistance? resistance occurred while deployment of the stent not while passing the device.Document review prior to distribution 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 of lot number c1835379 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1835379.It should be noted that the instructions for use (ifu0061-7) states the following: "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 not sufficient evidence to suggest the user did not follow the ifu.  root cause review  a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As noted during the lab evaluation the stent could be deployed and recaptured without issue.A possible root cause could be attributed to torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor kinking which combined with torturous anatomy could prevent the deployment of the stent.   summary complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.  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® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 12974260
• MDR Text Key: 289741896
• Report Number: 3001845648-2021-00857
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)230531(10)C1835379
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 05/12/2022

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: 05/31/2023
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1835379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/20/2021; 11/20/2021
• Supplement Dates FDA Received: 01/04/2022; 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• 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
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 45 KG