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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. LIFESTENT 5F VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 5F060603CS
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/20/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, pt had stent placed using lifestent vascular stent system in right femoral artery.On (b)(6) 2019, the pt underwent an aortogram/ angiogram at which time two foreign bodies were visualized in the right common iliac artery.Items appeared to be free flowing.The procedure was stopped and the pt was moved to the operating room for open operative retrieval of foreign bodies.One of the items was retrieved.The second item was unable to be retrieved.Post-op the pt was admitted to the hosp and discharged on (b)(6) 2019.The retained items were identified to be small (1.5 cm and 0.5 cm in length averaging 1.0 cm in diameter) broken pieces from the stent deployment mechanism that was used in the (b)(6) 2019 procedure.Fda safety report id# (b)(4).
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key9575587
MDR Text Key174666500
Report NumberMW5092148
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5F060603CS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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