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

Model Number	G48027
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• MDR Report Key: 9009407
• Report Number: 3001845648-2019-00470
• Device Sequence Number: 2332537
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)200822(10)C1532216
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR