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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
Catalog Number FEM10040
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
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 for the reported device/patient code(s) 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.(expiry date: 03/2023).
 
Event Description
It was reported that during a fistulogram procedure, the device was allegedly difficult to advance and had positioning failure.The procedure was completed using the same device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were 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.Investigation summary: a physical sample was returned and evaluation was performed which indicates that the outer sheath was identified detached from the swivel nut which indicates excessive force.Reportedly, there was difficulty advancing through the lesion; this issue may be related to insufficient flushing of the device or to the use of inadequate accessories.Possible damage to the packaging, storage, unpacking, or preparation may be other contributing factors.In this case, the device was flushed prior to use and a 6f introducer sheath was used which is not appropriate as the label was recommended to use 9f.However, a hydrophilic guidewire was used with a device which it is not known if it was kept hydrated at all the time.The outer sheath was identified detached from the swivel nut which may be related to the difficulty that was experienced during advancing.The investigation is confirmed for detachment of the outer sheath.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential factors.The instructions for use state: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.' under materials required the instructions for use state: 'introducer sheath with appropriate inner diameter', and the packaging labels indicate a minimum introducer size of 9f.Furthermore, the instructions for use state: '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.' h11: section a through f ¿ the information provide by bd represents all 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 bd.H3 other text : see h10.
 
Event Description
It was reported that during a fistulogram procedure, the device was allegedly difficult to advance and had positioning failure.The procedure was completed using the same device.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 Key11185075
MDR Text Key227541675
Report Number2020394-2020-21073
Device Sequence Number1
Product Code PFV
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 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFEM10040
Device Lot NumberANEQ3630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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