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

Catalog Number 5F060403CS

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Patient undergoing peripheral arterial procedure (angiography, angioplasty) in outpatient setting, md attempted to place a stent, md reported he was unable to deploy stent using rolling wheel on stent device, md attempted to retract and remove stent and was unable to do so.Nurse notified ems of need for medical transportation to local hospital.Ems arrived, pt transported to local hospital.Md notified nurse of intent to meet patient at the emergency room to give report to er physician.

• Brand Name: BARD LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 18913308
• MDR Text Key: 337913361
• Report Number: MW5152867
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060403CS
• Device Lot Number: ANGS0772
• 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 Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White