MAUDE Adverse Event Report: EV3, INC. PROTEGE GPS SELF EXPANDING NITINOL STENT SYSTEM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	SERB65-12-60-80
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Protégé gps self expanding peripheral stent system did not deploy from system.Fda safety report id# (b)(4).

• Brand Name: PROTEGE GPS SELF EXPANDING NITINOL STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): EV3, INC.; plymouth MN 55442 2920
• MDR Report Key: 13002438
• Report Number: MW5106030
• Device Sequence Number: 6010011
• Product Code: FGE
• UDI-Device Identifier: 00643169729179
• UDI-Public: (01)00643169729179
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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 Expiration Date: 01/01/2023
• Device Model Number: SERB65-12-60-80
• Device Catalogue Number: REF: SERB65-12-60-80
• Device Lot Number: B049465
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown