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

Model Number	G48032
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Information (3190)
Date of Event	04/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k)#: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The stent was removed after placing by the grasping the loop at the proximal end of the stent, the proximal end of the stent did no reopen once outside of the patient.This was questioned by the customer.The customer was concerned the proximal end of the stent had not fully opened.Did any piece of the device remain inside the patient¿s body? no.Please describe the object and how it was retrieved (if applicable):.Did the patient require any additional procedures due to this occurrence? unknown.Did the product cause or contribute to the need for additional procedure(s)? unknown.Did the complainant inform of any adverse effect(s) on the patient due to this occurrence? unknown.Did the complainant inform that the product caused or contributed to the adverse effect(s)? unknown.
Additional Manufacturer Narrative
Component code (annex g): g04122 ¿ stent.Pma/510(k) #: k162717.Device evaluation: the evo-20-25-12.5-e device of lot number c1574493 involved in this complaint device was not returned for evaluation.With the information and images provided document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-20-25-12.5-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-20-25-12.5-e device of lot number c1574493 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 #c1574493 ; upon review of complaints this failure mode has not occurred previously with this lot #c1574493.As per the instructions for use, ifu0061-6, which informs the user about the potential complications " additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth." there is no evidence to suggest that the customer did not follow the instructions for use.Additional information was requested to help us gain a better insight and to determine how long after implantation the stent was removed? if this information becomes available in the future then the file will be updated accordingly.As per engineering input, "i don¿t see any structural issues with the proximal stent end.It appears from the photo that due to the amount of tissue that remained it did not re-open from its withdrawal shape once outside of the body." as per medical advisor: "patient¿s discomfort was due to migration which subsequently led to occlusion" root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a complication following the placement of this device.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: according to the initial reporter, the patient outcome is unknown, removal of the stent due to migration- patient was not comfortable, as reported.Customer complaint is confirmed based on customer testimony and images provided.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10023307
• Report Number: 3001845648-2020-00271
• Device Sequence Number: 2937253
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)210109(10)C1574493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1574493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention