MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTENT 5F VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 5F060301CS

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

The tip of a self expanding stent catheter broke off in the patient after deployment of the stent.A snare was used to retrieve the tip but it broke into three pieces.One of the three pieces where retrieved.Patient returned to surgery following day for removal of other 2 pieces.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 12280104
• MDR Text Key: 265163412
• Report Number: 12280104
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5F060301CS
• Device Catalogue Number: 5F060301CS
• Device Lot Number: ANEY1160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2021
• Date Report to Manufacturer: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Weight: 91