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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
Device Problems Material Puncture/Hole (1504); Material Separation (1562); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records were provided to the manufacturer.Images were provided.The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during a stent graft placement procedure in the cephalic fistula, the stent graft was allegedly partially deploy.It was reported excessive force was applied to deploy the stent graft.It was further reported that half of the stent was allegedly stuck into the sheath and the other half was sticking out.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the stent was returned for evaluation without the delivery system.Visual evaluation identified bent struts and peeled outer graft at the same location of bends.Holes in the graft were also noted throughout the length of the stent.Therefore, the investigation is confirmed for hole in material and delamination as the graft had holes and the outer graft was peeling from the inner layer at the bent struts.However, the investigation is inconclusive for partial deployment as the stent was fully deployed and the delivery system was not returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
Event Description
It was reported that during a stent graft placement procedure in the cephalic fistula, the stent graft was allegedly partially deploy.It was reported excessive force was applied to deploy the stent graft.It was further reported that half of the stent was allegedly stuck into the sheath and the other half was sticking out.Another device was used to complete the procedure.There was no reported patient injury.
 
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Brand Name
FLAIR ENDOVASCULAR STENT GRAFT
Type of Device
STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7825334
MDR Text Key118541924
Report Number2020394-2018-01584
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008998
UDI-Public(01)04049519008998
Combination Product (y/n)N
PMA/PMN Number
P060002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFAS08050
Device Catalogue NumberFAS08050
Device Lot NumberANBP1154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
Date Manufacturer Received11/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
Patient Weight73
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