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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 Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 01/09/2019
Event Type  Injury  
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.
 
Event Description
It was reported that during a stent graft deployment procedure to treat in stent stenosis in the mid cephalic, the radiopaque ring allegedly became stuck on the distal end of the stent and the catheter fractured during a deployment attempt.It was further reported the stent graft did not properly deploy and the radiopaque ring detached and migrated to the right lower lung confirmed by x-ray.The foreign body is not of concern as its placement in the lower medial lobe of the right lung is outweighed by the risk of removal.There was no reported patient injury.
 
Manufacturer Narrative
This supplemental mdr is being submitted to report this event is reportable as a serious injury as additional intervention was initially attempted to retrieve the component.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.
 
Event Description
It was reported that during a stent graft deployment procedure to treat in stent stenosis in the mid cephalic, the radiopaque ring allegedly became stuck on the distal end of the stent and the catheter fractured during a deployment attempt.It was further reported the stent graft did not properly deploy and the radiopaque ring detached and migrated to the right lower lung confirmed by x-ray.The foreign body is not of concern as its placement in the lower medial lobe of the right lung is outweighed by the risk of removal.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.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.Investigation summary: the device was not provided for evaluation.Based on x-ray provided, the detached tip could not be definitely identified.Based on the information provided the reported problem could not be confirmed and the investigation is closed with inconclusive result.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant ifu for this product, the potential issue was found addressed.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 deployment and potential factor of the reported issue the ifu states: "the use of an appropriately sized introducer sheath is recommended"; "pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter"; "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure"; "do not kink the delivery catheter or use excessive force during delivery to the target lesion." regarding the possibility of a damaged device prior to use the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.".
 
Event Description
It was reported that during a stent graft deployment procedure to treat in stent stenosis in the mid cephalic, the radiopaque ring allegedly became stuck on the distal end of the stent and the catheter fractured during a deployment attempt.It was further reported the stent graft did not properly deploy and the radiopaque ring detached and migrated to the right lower lung confirmed by x-ray.The foreign body is not of concern as its placement in the lower medial lobe of the right lung is outweighed by the risk of removal.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 Key8337527
MDR Text Key136146579
Report Number2020394-2019-00124
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,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2020
Device Model NumberFEM12060
Device Catalogue NumberFEM12060
Device Lot NumberANBT0874
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
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