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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 FEM14060
Device Problems Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2019
Event Type  malfunction  
Event Description
It was reported that during a stent graft placement in the left innominate vein via basilic outflow access in the left upper arm, the healthcare provider allegedly felt friction during the deployment attempt.Reportedly, the healthcare provider retracted the stent graft before it released from the inner catheter.Furthermore, a new device was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during a stent graft placement in the left innominate vein via basilic outflow access in the left upper arm, the healthcare provider allegedly felt friction during the deployment attempt.Reportedly, the healthcare provider retracted the stent graft before it released from the inner catheter.Furthermore, a new device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: review of manufacturing records was not required, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 all specifications prior to shipment.Investigation summary: a stent graft delivery system was returned for evaluation.On the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The outer sheath was found elongated, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.Furthermore, the outer sheath was found perforated by stent graft strut, which made a stent graft deployment impossible.No indication was found for manufacturing related issues.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with 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 anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint 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." regarding the use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter ".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." h10: d4(expiry date: 11/2021), g4 h11: h3, h6(method, results, conclusion).
 
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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 Key8509359
MDR Text Key141770436
Report Number9681442-2019-00050
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008691
UDI-Public(01)04049519008691
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
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2021
Device Model NumberFEM14060
Device Catalogue NumberFEM14060
Device Lot NumberANCY0420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received04/12/2019
Supplement Dates Manufacturer Received06/14/2019
Supplement Dates FDA Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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