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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 FEM12060
Device Problems Positioning Failure (1158); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 basilic vein, the delivery system allegedly caught with the radiopaque markers of the stent graft.It was further reported the device was removed without incident and lesion was ballooned in place.Reportedly, the procedure has been rescheduled to an unspecified date.There was no reported patient injury.
 
Manufacturer Narrative
A manufacturing review was performed.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Based on the investigation of the returned sample, a deployment failure could be confirmed.The stent graft was found fully loaded and could not be deployed during evaluation testing because of high release force; the system was bloody and the safety clip was not returned.Allegedly, the stent graft could not be deployed because of sheath marker interaction, however, during sample evaluation an interaction between sheath marker and stent graft marker could not be confirmed as reason for the deployment failure.High friction was considered as reason for high release force and subsequent deployment failure.No indication could be found for a process related issue.Potential factors which may have caused or contributed to the reported issue have been considered.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.In reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding the use of accessories the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter' and 'the use of an appropriately sized introducer sheath is recommended.' furthermore, the ifu states: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment.' (b)(4).
 
Event Description
It was reported that during a stent graft placement procedure in the basilic vein, the delivery system allegedly caught with the radiopaque markers of the stent graft.It was further reported the device was removed without incident and lesion was ballooned in place.Reportedly, the procedure has been rescheduled to an unspecified date.There was no reported patient injury.
 
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Brand Name
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Type of Device
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7316723
MDR Text Key101730530
Report Number2020394-2018-00193
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008646
UDI-Public(01)04049519008646
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/20/2018
Device Model NumberFEM12060
Device Catalogue NumberFEM12060
Device Lot NumberANZK2844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Date Manufacturer Received04/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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