MAUDE Adverse Event Report: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Patient's stenosis is 8 cm long.User cannot see the stent under x-ray image during stent deployment, and there was a sound like slam while the marker at 1/3 position, but user didn't stop deployment after the sound and pulled the safety wire out.The stent cannot be saw during the whole deployment because of the contrast accumulation, and the yellow marker cannot be saw either because it was covered by excrement.User complete the deployment of stent by experience until marker reached terminal point and the trigger cannot be pulled.User retracted the device from patient afterward and found out the stent was still inside sheath.User changed another same device to complete the procedure.

Manufacturer Narrative

510(k) number: k163468 this report is being submitted as a cancellation report.From the initial information received, this event was cautiously made reportable based on the precedence in place for this device of 'flexor kinked/stretched/broken/compressed'.However, when the returned device was received it was confirmed during the lab evaluation that this malfunction did not occur.The following failure has been confirmed: "shuttle assembly does not remain intact, stent cannot be deployed.Replacement device required".Overall risk assessed as category iii (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

Event Description

Patient's stenosis is 8 cm long.User cannot see the stent under x-ray image during stent deployment, and there was a sound like slam while the marker at 1/3 position, but user didn't stop deployment after the sound and pulled the safety wire out.The stent cannot be saw during the whole deployment because of the contrast accumulation, and the yellow marker cannot be saw either because it was covered by excrement.User complete the deployment of stent by experience until marker reached terminal point and the trigger cannot be pulled.User retracted the device from patient afterward and found out the stent was still inside sheath.User changed another same device to complete the procedure.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• MDR Report Key: 9009407
• MDR Text Key: 159677191
• Report Number: 3001845648-2019-00470
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)200822(10)C1532216
• 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: 09/12/2019

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
• Device Operator: Health Professional
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1532216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR