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

Model Number	G48033
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 k #: k162717.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event described by dr.(b)(6): after placing an.035 stiff wire through the scope, under fluoro, the stent was advanced on the stiff guide wire, after positioning it well , they started to deploy the stent.Unfortunately they could not see the stent opening under x-ray.The red visual marker on the top of the handle was coming backward , but even after it reaches point of no return the proximal end of the stent was not opening.The metal stylet was removed but still they could not deploy the stents.The whole assembly was taken out of the patient.Even in the air the stent was not opening.The procedure was completed using other company stent.
Additional Manufacturer Narrative
K162717 - 510 k # investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event described by dr.(b)(4) ,after placing an.035 stiff wire through the scope ,under floro , the stent was advanced on the stiff guide wire, after positioning it well , they started to deploye the stent , unfortunetly they could not see the stent opening under xray, the red visusal marker on the top of the handle was coming backward , but even after it reaches point of no return the proximal end of the stent was not opening , the metal stylet was removed but still they could not deploy the stents , the whole assembly was taken out of the patient , even in the air the stent was not opening.The procedure was completed using other company stent.
Event or Problem Description
Event described by dr.(b)(6) ,after placing an.035 stiff wire through the scope ,under floro , the stent was advanced on the stiff guide wire, after positioning it well , they started to deploy the stent , unfortunately they could not see the stent opening under xray, the red visual marker on the top of the handle was coming backward , but even after it reaches point of no return the proximal end of the stent was not opening , the metal stylet was removed but still they could not deploy the stents , the whole assembly was taken out of the patient , even in the air the stent was not opening.The procedure was completed using other company stent.
Additional Manufacturer Narrative
K162717 - 510 k #.Lab evaluation: the evo-20-25-15-e device of lot number (b)(6) was not returned for evaluation.With the information provided, document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-20-25-15-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-20-25-15-e device of lot number (b)(6) 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 #(b)(6); upon review of complaints this failure mode has not occurred previously with this lot #(b)(6).The instructions for use ifu0061-6 which accompanies this device instructs the user to "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization" there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the tortuous patient anatomy lead to the stent deployment difficulties inside the patient and this difficulty was also present on the device outside the patient as the device had been impacted by the tortuous patient anatomy." however, as the device was not returned for evaluation and additional questions were not answered; the cause of this complaint could not be conclusively determined.Summary: customer complaint is confirmed based on customer testimony.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
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9642838
• Report Number: 3001845648-2020-00066
• Device Sequence Number: 2185404
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)200410(10)C1472677
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2020

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: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1472677
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020; 01/06/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/26/2020; 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1