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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 FEM10040
Medical Device Problem Codes Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The lot number for the malfunction was provided and a lot history review was performed.The investigation was inconclusive for the alleged deployment malfunction.The root cause could not be determined.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates model fem10040, endovascular stent graft, allegedly failed to deploy and misfired.The information was received from a single source.This malfunction involved a (b)(6) year old male weighing 130 pounds, there were no patient consequences.
 
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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 Key9188648
Report Number2020394-2019-03913
Device Sequence Number19407673
Product Code PFV
UDI-Device Identifier04049519008585
UDI-Public(01)04049519008585
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 NumberFEM10040
Device Catalogue NumberFEM10040
Device Lot NumberANCS1781
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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