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

Catalog Number	EVO-20-25-10-E
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	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the stent was returned to cirl.The delivery system was not returned.Upon evaluation of the stent it was observed that the stent looked ok and functionally of the stent was fine.There was no evidence of damage to the stent.A definitive cause for the customer¿s complaint was unable to be determined because the delivery system was not returned for evaluation and also actual use conditions could not be duplicated in the laboratory setting.The customer complaint was confirmed based on the customers testimony as the delivery system was not returned for evaluation and also the failure could not be replicated.A review of the manufacturing records for the evo-20-25-10-e device of lot number c1167910 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution all evo-20-25-10-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.Information provided indicates that 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.
Event or Problem Description
The procedure to place the evo biliary stent went smoothly until the time came to remove the introduction system.The user noted via fluoroscopy that the stent was moving also when the introduction system was been withdrawn.The user ended up removing the whole system (introduction system and stent) from the patient.Event meets mdr reporting criteria based on the malfunction precedence for this device family for 'a deployment issue resulting in the exposed stent being removed from the patient with the delivery system'.

• 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: 5467397
• Report Number: 3001845648-2016-00054
• Device Sequence Number: 330527
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)171102(10)C1167910
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080359
• 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
• Report Date (Section B): 02/01/2016

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 Catalogue Number: EVO-20-25-10-E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2016
• Initial Report FDA Received Date: 02/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1