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

Model Number	PRB35-08-040-120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After deploying the stent when removing device, the inner sheath came apart from the device and almost left inside the patient.

• Brand Name: EVERFLEX
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3, INC.; 4600 nathan lane; plymouth MN 55442
• MDR Report Key: 7624622
• Report Number: 7624622
• Device Sequence Number: 16612328
• Product Code: NIP
• UDI-Device Identifier: 00821684069509
• UDI-Public: (01)00821684069509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2018
• Report Date (Section F): 06/15/2018

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: Physician
• Device Expiration Date: 08/15/2020
• Device Model Number: PRB35-08-040-120
• Device Lot Number: A509044
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/15/2018