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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS VASCULAR STENT GRAFT
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BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL14100
Device Problems Fracture (1260); Material Separation (1562); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2018
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.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 treatment for an abdominal aortic aneurysm after successfully implanting an aortic stent graft, the vascular stent graft allegedly partially deployed during deployment in one of the branch extensions.Reportedly, the delivery system was removed without incident and exchanged for another to successfully complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during treatment for an abdominal aortic aneurysm after successfully implanting an aortic stent graft, the vascular stent graft allegedly partially deployed during deployment in one of the branch extensions.Reportedly, the delivery system was removed without incident and exchanged for another to successfully complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the stent graft could only be partially released.The outer catheter was found with elongation which indicated that a high release force was present during deployment attempt.Furthermore, the partially deployed segment of the stent graft was found damaged with stent strut fracture and covering separation.As a result of the investigation performed the complaint was confirmed.A definite root cause for the reported event could not be determined.However, the reported application represents an off label use of the device.Labeling review: in reviewing the current labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that 'prior to loading the vascular 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: 'prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' the reported application represents an off label use.Based on the ifu the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.
 
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Brand Name
FLUENCY PLUS VASCULAR STENT GRAFT
Type of Device
VASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7291272
MDR Text Key100909991
Report Number9681442-2018-00019
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145360
UDI-Public(01)00801741145360
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,foreig
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/13/2020
Device Catalogue NumberFVL14100
Device Lot NumberANBN1400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Date Manufacturer Received03/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight65
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