MAUDE Adverse Event Report: EV3, INC EVERFLEX¿ PROTÉGÉ¿ EVERFLEX¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	PRB35-06-150-120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Providers could not get the stent to deploy in the superficial femoral artery.When they removed the device, the provider looked at it and attempted to deploy the stent, again, without success.

• Brand Name: EVERFLEX¿ PROTÉGÉ¿ EVERFLEX¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3, INC; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 23778207
• Report Number: 23778207
• Device Sequence Number: 15997045
• Product Code: NIP
• UDI-Device Identifier: 00821684059982
• UDI-Public: (01)00821684059982(17)280616(10)C125972
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/07/2025
• Report Date (Section F): 10/07/2025

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: PRB35-06-150-120
• Device Lot Number: C125972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/07/2025