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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT
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BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FEM14060
Medical Device Problem Codes Break (1069); Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
One device and an image were returned for evaluation.The lot history review was performed.The investigation confirmed for a break, positioning failure, and difficult to remove.A root cause could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the information indicated that model fem14060 endovascular stent graft allegedly failed to deploy, broke, and was difficult to remove.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.
 
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Brand Name
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Common Device Name
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9188722
Report Number2020394-2019-03917
Device Sequence Number11305773
Product Code PFV
UDI-Device Identifier04049519008691
UDI-Public(01)04049519008691
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/14/2019
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 No Information
Device Model NumberFEM14060
Device Catalogue NumberFEM14060
Device Lot NumberANCY2210
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/14/2019
Patient Sequence Number1
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