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

Catalog Number EVO-20-25-12.5-E

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Upon evaluation of the returned device, it was noted that the device was returned in two pieces.All pieces were present.The safety wire and the stent were not present with the returned device.The red safety tab was at the point of no return.The handle was actuated and no issue was noted.It was observed that the peak broke at the distal end of the bilumen.The (b)(4) research & development engineer commented that the tip part of the catheter broke as a result of the tip not being able to retract.Damage to the outer sheath was noted.The (b)(4) research & development engineer also commented that the compression and damage evident to the outer sheath would have occurred as a result that the lockwire was still attached when the physician attempted to retract the device.Also, following device evaluation, the (b)(4) research & development engineer has commented that the root cause of this complaint is user error ¿ they past the point of no return without deploying the lockwire as per instructions for use.The customer complaint was not confirmed based on the information provided and the evaluation of the returned device which signify user error as they past the point of no return without deploying the lockwire as per instructions for use.The instructions for use:¿when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.Continue deploying stent by squeezing trigger.¿ it was confirmed that ¿the stent is remaining in the patient¿s body.¿ prior to distribution, all evo-20-25-12.5-e devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in (b)(4).It was confirmed that the stent was not placed in the desired lesion, therefore another stent placement is scheduled.The patient's condition uncovered.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

A (b)(6) female patient underwent esophageal stent placement.When the doctor attempted to remove the delivery system after he placed the stent at desired lesion, he felt resistance.He thought that the stent was not completely deployed due to severe stenosis, so the tip of the device got stuck.Since the tip of the inner catheter got stuck at the stenosis area, he attempted to advance the outer sheath by pushing the button to the opposite side and advance the outer sheath to remove the device smoothly, however, the device could not be removed.While the stent deployed, he pulled the safety wire until some of the safety wire came out, he confirmed that the proximal stent deployed.He tried to remove all of the wire, but he was unable to do this.Therefore, he removed the wire out with force, then the inner catheter separated from the delivery system about 15cm from the tip of the device.After removal of the delivery system out of the patient's body, the ruptured inner catheter was retrieved using a snare through the scope.The physician advanced the endoscope into the placed stent to retrieve the ruptured inner catheter.It was confirmed that the stent was not placed in the desired lesion after he retrieved the ruptured inner catheter, therefore, another stent placement is scheduled.

• 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
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5666072
• MDR Text Key: 45484595
• Report Number: 3001845648-2016-00132
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)170805(10)C1136309
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: EVO-20-25-12.5-E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 93 YR