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

Model Number 5F070203CS

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Surgeon wanted to implant a stent into femoral artery, she said that the deployment device felt funny so she took the device out of the patient and decided to use a different stent.Stent info: stnt vasc 7mm 20mm 135cm 5fr model # 5f070203cs, lot# anex3008.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM 5F
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 17020120
• MDR Text Key: 316223310
• Report Number: MW5117963
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: 5F070203CS
• Device Catalogue Number: 5F070203CS
• Device Lot Number: ANEX3008
• 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
• Patient Age: 61 YR
• Patient Sex: Male