Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENOVASCULAR STENT GRAFT; ENDOVASCULAR STENT GRAFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENOVASCULAR STENT GRAFT; ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FEM10100
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Misfire (2532)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Lethargy (2560)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bd 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 bd.
 
Event Description
It was reported that during a stent graft placement procedure to treat stenosis in a forearm loop graft, the stent graft allegedly partially deployed.It was further reported that the device was difficult to remove, therefore the sheath and delivery system were removed as one unit.Furthermore, upon removal, the patient's blood pressure dropped and became unresponsive.The patient was admitted to the emergency room and is currently stable.
 
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: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported issue could be confirmed.Upon sample receipt the stent graft was found to be stuck inside an introducer sheath and the outer sheath was found to be elongated which indicated that high friction was present during treatment.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.Labeling review: 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 (.)".
 
Event Description
It was reported that during a stent graft placement procedure to treat stenosis in a forearm loop graft, the stent graft allegedly partially deployed.It was further reported that the device was difficult to remove, therefore the sheath and delivery system were removed as one unit.Furthermore, upon removal, the patient's blood pressure dropped and became unresponsive.The patient was admitted to the emergency room and is currently stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLUENCY PLUS ENOVASCULAR STENT GRAFT
Type of Device
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8291010
MDR Text Key134571509
Report Number2020394-2019-00091
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008615
UDI-Public(01)04049519008615
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 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/24/2021
Device Model NumberFEM10100
Device Catalogue NumberFEM10100
Device Lot NumberANCV3754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
-
-