MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 5F050603CS

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2021

Event Type  Injury  

Event Description

Pt had a heart and leg angiogram today.While fixing her leg, placed 2 stents.Once the stent was removed, we noticed a piece of product was left in the body, in her right leg.Attempted to retrieve for a couple hours, with various techniques.Able to retrieve one piece, however, unable to retrieve the second piece.It is crushed up against side wall of artery in right leg with a stent.Fda safety report id# (b)(4).

• Brand Name: BARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 12050214
• MDR Text Key: 258200384
• Report Number: MW5102045
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5F050603CS
• Device Catalogue Number: 5F050603CS
• Device Lot Number: ANET3522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other