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

Model Number G48032

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

"i contacted the pharmacist mr (b)(6), who confirms the placement of three prostheses on the same patient; (b)(4) - the first did not open, it is a complaint.(b)(4) - the second has moved but it is not complaint, it is a failure to placed- echec de pose ( usually manipulation issue by doctor or patient anatomy but not related to the product it self ) [this medwatch report] the third was placed ( no issue there).

Manufacturer Narrative

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

Event Description

Supplemental report required to capture additional information: update (b)(6) 2021: "the doctor himself admits that it is an error of judgment on his part, he should have fitted a longer stent to avoid this migration".Update (b)(6) 2021: "the stent was deployed in a correct location, the error done by doctor is that he selected a stent size not adapted to patient anatomy resulting a migration".Update (b)(6) 2021: "as far i understood the patient was ok , they removed the stent easily during same procedure and place another one with correct sizing successfully".

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation the evo-20-25-12.5-e device of lot number c1789114 involved in this complaint was not available for evaluation.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.With the information provided, a document-based investigation was conducted.Document review prior to distribution evo-20-25-12.5-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-12.5-e of lot number c1789114 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 c1789114.It should be noted that the instructions for use (ifu0061-7) states the following: "a complete diagnostic must be performed prior to use to determine proper stent size".There is sufficient evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause of user error was identified from the available information ¿ ¿the stent was deployed in a correct location, the error done by doctor is that he selected a stent size not adapted to patient anatomy resulting a migration¿ summary: customer complaint is confirmed based on customer testimony.According to the reporter, the patient did not experience any adverse effects due to this occurrence "the patient was ok , they removed the stent easily during same procedure and place another one with correct sizing successfully." complaints of this nature will continue to be monitored for potential emerging trends.Note that this file is related to (b)(4) (3001845648-2021-00388) (failed expansion of first device).

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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11825055
• MDR Text Key: 280756325
• Report Number: 3001845648-2021-00389
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)230105(10)C1789114
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1789114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2021
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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