MAUDE Adverse Event Report: EV3 INC. /COVIDIEN LLC PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PRB35-05-120-120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

The everflex stent 5x120x120 was deployed over a.035 wire without difficulty.Dr allen removed the stent catheter from the body and noticed the end of the catheter was missing.Dr (b)(6) then removed the wire and found the tip and end of stent catheter attached to wire.(implant ref# prb35-05-120-120, lot: b340492 ev3 everflex stent).Fda safety report id# (b)(4).

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): EV3 INC. /COVIDIEN LLC; plymouth MN 55442
• MDR Report Key: 14548064
• MDR Text Key: 293145897
• Report Number: MW5109989
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRB35-05-120-120
• Device Lot Number: B340492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1