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

Model Number PRB35-08-040-120

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Event 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3, INC.; 4600 nathan lane; plymouth MN 55442
• MDR Report Key: 7624622
• MDR Text Key: 111996031
• Report Number: 7624622
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684069509
• UDI-Public: (01)00821684069509
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 06/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1