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

Model Number G48033

Device Problems Insufficient Information (3190); Activation Failure (3270)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k162717.The investigation is in progress and a follow up mdr will be submitted.

Event Description

As per source doc: "customer indicated that they couldn't place the product".

Manufacturer Narrative

Pma/510(k) #k162717.Device evaluation  the evo-20-25-15-e device of lot number c1870388 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Several attempts were made to obtain additional information regarding this device.However, no response has been received to date.If it is returned in the future then the file will be updated accordingly.Document review including ifu review: prior to distribution evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-15-e of lot number c1870388 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 c1870388.It should be noted that the instructions for use (ifu0061) 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 from the available information.Due to the limited information available it was agreed with engineering that assigning the most common inability to deploy failure mode section would be the most appropriate approach in this case.Typically the most common possible root cause attributed to inability to deploy has been tortuous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure and resulting in deployment difficulties.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: the complaint is confirmed based on customer testimony.It is unknown whether the patient experienced 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.

Manufacturer Narrative

Pma/510(k) #k162717.Device evaluation.The evo-20-25-15-e device of lot number c1870388 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Several attempts were made to obtain additional information regarding this device.However, no response has been received to date.If it is returned in the future then the file will be updated accordingly.Document review including ifu review: prior to distribution evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-15-e of lot number c1870388 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 c1870388.It should be noted that the instructions for use (ifu0061) 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 from the available information.Due to the limited information available it was agreed with engineering that assigning the most common inability to deploy failure mode section would be the most appropriate approach in this case.Typically the most common possible root cause attributed to inability to deploy has been tortuous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure and resulting in deployment difficulties.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary.The complaint is confirmed based on customer testimony.It is unknown whether the patient experienced 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 a correction to the rpn from evo-20-25-12.5-e to evo-20-25-15-e.The investigation has also been completed and the investigation conclusions have been updated.

• 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: 13257073
• MDR Text Key: 294863998
• Report Number: 3001845648-2022-00017
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)230922(10)C1870388
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/22/2023
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1870388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2021
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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