MAUDE Adverse Event Report: COOK MEDICAL EVOLUTION DUODENAL STENT SYSTEM - UNCOVERED; DUODONAL STENT

Model Number EVO-22-27-6-D

Device Problems Unraveled Material (1664); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/06/2014

Event Type  Injury  

Event Description

Retained foreign body: on (b)(6) the patient underwent an egd with stent placement.A guidewire was advanced past the stricture under fluoroscopic visualization.Under endoscopic and fluoroscopic visualization a 22mm x 6mm cook evolution duodenal stent was advanced over the guidewire.Yellow marker was visualized proximal to the stricture.The firing gun did not allow for the stent to deploy completely.Wire cutters were used to disengage the delivery system and endoscope was withdrawn.A portion of the stent remained distal to the stricture.Later that day, the patient underwent another egd for retrieval of the stent and placement of another stent.The manufacturer's representative was present during the second procedure to inspect the prior stent malfunction.It appeared that the previous stent unraveled during deployment.Attempts were made to retrieve the prior stent but it became apparent that the remainder of the stent would not unravel and could not be retrieved.The subsequent stent was placed successfully.Contrast was injected through the stricture which confirmed successful stent deployment.There was no evidence of any leak.The wires fro the prior stent did not appear to be imbedded in any mucosa.

• Brand Name: EVOLUTION DUODENAL STENT SYSTEM - UNCOVERED
• Type of Device: DUODONAL STENT
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 3835717
• MDR Text Key: 19086146
• Report Number: MW5036275
• Device Sequence Number: 1
• Product Code: MUM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2014

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: Other
• Device Model Number: EVO-22-27-6-D
• Device Catalogue Number: G48025
• Device Lot Number: C888409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 64