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

Model Number	5F050303CS
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Nose cone and stent cover sheath broke off in the patient's vessel.Fda safety report id# (b)(4).

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC; tempe AZ 85281
• MDR Report Key: 10332174
• Report Number: MW5095747
• Device Sequence Number: 3854020
• Product Code: NIP
• UDI-Device Identifier: 00801741120602
• UDI-Public: (01)00801741120602(17)210208
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: 5F050303CS
• Device Lot Number: ANDP0981
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 66