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

Model Number G48031

Device Problems Difficult or Delayed Activation (2577); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

510k number: k162717.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Stent deployed successfully but stent came out with introducer even though removal pin removed.

Event Description

Stent deployed successfully but stent came out with introducer even though removal pin removed.

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the evo-20-25-10-e device of lot number c1615585 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 14th feb 2020.Stent found to be fully deployed on return and detached from the delivery system.Handle was actuating fine and stent fully intact.Following the laboratory evaluation additional information was requested to aid with this investigation to determine what was maintaining contact between stent and delivery system and at what point safety wire removed: -what was the position of the stent once the device was removed from patient? distal oesophagus.-what was maintaining the contact between stent and the delivery system? delivery system tip.-at what point was the safety wire removed? point of no return.Documents review including ifu review: 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.A review of the manufacturing records for evo-20-25-10-e device of lot number c1615585 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 #c1615585; upon review of complaints this failure mode has not occurred previously with this lot #c1615585.The instructions for use ifu0061-6 which accompanies this device instructs the user to "when stent point-of-no return has passed, pull safety wire out of delivery handle near wire guide port" "after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed." 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 as the circumstances of use cannot be replicated in the laboratory.From additional information received, after deployment, full stent expansion was fluoroscopically confirmed, therefore there may be many possible root causes for the issue encountered, some may include the following: a possible root cause could be attributed to the difficult target site which could lead to a stent getting caught up on the delivery system tip, user technique or the suture getting caught up on the bi-lumen.Summary: according to the initial reporter, the patient did require any additional procedures due to this occurrence.Another stent was used.Customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9744845
• MDR Text Key: 217993503
• Report Number: 3001845648-2020-00119
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)210522(10)C1615585
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1615585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1