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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 FEM14080
Device Problem Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a vascular stent deployment procedure in the subclavian artery via upper arm graft approach, the stent allegedly deployed partially.The delivery system was able to be removed through the introducer sheath without issues from the patient.Reportedly, an alternative balloon was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
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.A stent graft delivery system was returned.Based on the evaluation of the returned sample the partially stent graft deployment could be confirmed.The outer sheath was found to be elongated which indicated that high friction and high release force were present during the treatment which subsequently led to a partially deployed stent graft.During evaluation testing an attempt was made to deploy the stent graft completely; the deployment test was not successful.An indication for a manufacturing related issue could not be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.In reviewing the valid labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device 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." regarding the anatomy of the placement site the ifu states: "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".Furthermore, 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".(expiry date 06/2021).
 
Event Description
It was reported that during a vascular stent deployment procedure in the subclavian artery via upper arm graft approach, the stent allegedly deployed partially.The delivery system was able to be removed through the introducer sheath without issues from the patient.Reportedly, an alternative balloon was used to complete the procedure.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 Key8090080
MDR Text Key127914005
Report Number2020394-2018-02091
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008707
UDI-Public(01)04049519008707
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 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFEM14080
Device Catalogue NumberFEM14080
Device Lot NumberANCT2096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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