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); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
K162717 - us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The prosthesis was introduced over a guidewire.After positioning it in the ideal location, deployment started.When deployng (squeeze the trigger) for the first time, we heard an unusual "crack" and then realized from the scope that the prosthesis was not opening.When removing the prosthesis, it was observed that the tip was with a disruption.
Additional Manufacturer Narrative
K162717 - us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The prosthesis was introduced over a guidewire.After positioning it in the ideal location, deployment started.When deployng (squeeze the trigger) for the first time, we heard an unusual "crack" and then realized from the scope that the prosthesis was not opening.When removing the prosthesis, it was observed that the tip was with a disruption.
Event or Problem Description
The prosthesis was introduced over a guidewire.After positioning it in the ideal location, deployment started.When deploying (squeeze the trigger) for the first time, we heard an unusual "crack" and then realized from the scope that the prosthesis was not opening.When removing the prosthesis, it was observed that the tip was with a disruption.
Additional Manufacturer Narrative
Pma/510(k)#: k162717.The evo-20-25-12.5-e device of lot number c1564001 involved in this complaint device was not returned for evaluation.With the information and images provided document based investigation was conducted.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 c1564001 did not reveal any discrepancies that could have contributed to this issue.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is evidence to suggest that the customer did not follow the instructions for use.Additional information was requested to help us gain a better insight.From additional information provided: when was the crack in the tip noticed? as there was a noise when pulling the trigger the first time, the prosthesis was removed and, at that moment, the crack was notice.It is stated that the stent did not deploy at all but it is also stated that the entire stent contacted the patient, please clarify.In fact, perhaps i may have misunderstood the question.When it is said that it was not deploy, it means that it did not remain inside the patient.The product was used, introduced through the guide wire to the desired location, so we inform you that there was contact with the patient." upon further investigation, it was concluded that the white tip was not damaged and in comparison with finished product, it appears to be grooved as intended.As per production supervisor input "the compressions highlighted below are a normal feature of the stent.It is more pronounced on the larger sizes such as the 12.5s and 15s.It is impossible to tell from the pictures below about the condition of the device.From the previously attached pictures it is noted that the red tab on the handle is all the way back, indicating that the stent was deployed.The retaining wire does not appear to be still at the rear of the handle, indicating that this was removed at some stage.From the information provided in the reports, the sequence of events leading to the device complaint are unclear.However, what is evident is that there was attempt to actuate the handle and that the retaining wire was removed.It would seem to me to be very unusual that the retaining wire was removed if the stent had not deployed correctly." a definitive root cause could not be determined from the available information.From the information and images provided a possible root cause could be attributed to tortuous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the deployment difficulties.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Customer complaint is confirmed based on customer testimony and images provided.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 9416983
• Report Number: 3001845648-2019-00675
• Device Sequence Number: 10888383
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)201129(10)C1564001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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
• Operator of Device: No Information
• Device Expiration Date: 11/29/2020
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1564001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019; 11/11/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/02/2020; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR