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

Model Number	G52225
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	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue that results in the exposed stent removed from the patient with the delivery system.¿ user pull the trigger but the stent was not released.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana.47402-4195.Importer site establishment registration number:(b)(4).Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 06th march 2019.There was no functional issues noted and stent deployed without issues, no defect observed.Following the laboratory evaluation additional information was requested to aid with the investigation.The images provided show the red indicator at the front of the handle indicating that the stent was recaptured.The lock wire is also removed, was the lock wire pulled at the point of no return? yes.When was the stent recaptured? after locking wire removed and 50% stent released.Did the product fail during stent deployment or recapture? yes.Stent cannot be released after releasing 50%.Was the directional button pressed during use? yes, once.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.50% stent released please advise if they tried to recapture because they couldn¿t release the stent? yes if the stent did not deploy because they were in the recapture mode? no.The mode is in releasing mode did they tried to reposition the stent? yes, at 30% stent releasing.Can i confirm if the stent could be re-captured into the deployment system before removal from the patient? yes or was the stent exposed while being removed from the patient? no.Prior to distribution all evo-fc-20-25-8-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-fc-20-25-8-e device of lot number c1485908 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 #c1485908; upon review of complaints this failure mode has not occurred previously with this lot #c1485908.The instructions for use ifu0061 -5 which accompanies this device instructs the user to "if stent repositioning is required during deployment, it is possible to recapture stent.Note: it is not possible to recapture stent after passing point -of - no return, indicated when red marker on top of introducer has passed the point - of - no return indicator on handle.When stent point- of- no return has been passed, pull safety wire out of delivery handle near wire guide port." there is no evidence to suggest that the customer did not follow the instructions for use ifu0061 -5.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to a patient anatomy as noted in additional information received there was a resistance felt passing the through stricture.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue that results in the exposed stent removed from the patient with the delivery system¿ user pull the trigger but the stent was not released.User changed another same device to complete the procedure.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8469146
• Report Number: 3001845648-2019-00131
• Device Sequence Number: 19248503
• Product Code: ESW
• UDI-Device Identifier: 10827002522258
• UDI-Public: (01)10827002522258(17)200518(10)C1485908
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 05/18/2020
• Device Model Number: G52225
• Device Catalogue Number: EVO-FC-20-25-8-E
• Device Lot Number: C1485908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR