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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT
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BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FAS08050
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for failure to deploy.Based upon the available information, the definitive root cause for this event 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 fas08050 endovascular stent graft allegedly experienced failure to deploy.This information was received from one source.The malfunction had patient involvement, but the patient had no consequences.The (b)(6) year old female patient was (b)(6) lbs.
 
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Brand Name
FLAIR 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 Key10735127
Report Number2020394-2020-06068
Device Sequence Number11291041
Product Code PFV
UDI-Device Identifier04049519008998
UDI-Public(01)04049519008998
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) 10/26/2020
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 No Information
Device Model NumberFAS08050
Device Catalogue NumberFAS08050
Device Lot NumberANBZ0247
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/26/2020
Patient Sequence Number1
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