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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 FEM12040
Medical Device Problem Codes Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device was returned to bd for evaluation.The investigation was identified for misfire and material perforation.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem12040 endovascular stent graft allegedly experienced failure to deploy, misfire, and material perforation.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient was a (b)(6) year old female and weight was not reported.
 
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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 Key9187895
Report Number2020394-2019-03904
Device Sequence Number2538166
Product Code PFV
UDI-Device Identifier04049519008639
UDI-Public(01)04049519008639
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 a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberFEM12040
Device Catalogue NumberFEM12040
Device Lot NumberANBX2693
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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