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. FLAIR 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. FLAIR ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FAF07040
Device Problems Break (1069); Positioning Failure (1158); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
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 has been returned for evaluation.The investigation is currently underway.
 
Event Description
It was reported that during a stent graft deployment procedure for arterial anastomosis through an upper arm fistula, the stent graft allegedly failed to deploy.It was further reported that the proximal end of the device near the handle broke.A balloon angioplasty was then used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during a stent graft deployment procedure for arterial anastomosis through an upper arm fistula, the stent graft allegedly failed to deploy.It was further reported that the proximal end of the device near the handle broke.A balloon angioplasty was then used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this 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 reported to date for this lot number and failure mode.Investigation summary: one flair endovascular stent graft was returned for evaluation.Two electronic photos were provided.The visual inspection and photos identified a break in the outer catheter.Stretching was identified on both sides of the outer catheter break.The coiled portion of the catheter was found to be bent approximately 6.7cm from the strain relief.The distal tip of the outer catheter was slightly deformed.Bunching of the outer catheter just proximal of the marker band was identified.The stent graft was in place and not released.Complete functional testing was unable to be performed due to the catheter break.The investigation is confirmed for break, failure to deploy, and material deformation.The stent graft ultimately could not be deployed because the outer catheter broke.It is possible that the user experienced high frictional deployment forces which led to the outer catheter break and deformation of the catheter.High deployment forces and increased friction may be caused be a difficult patient anatomy, insufficient flushing of the device prior to use as well as use of inadequate accessories.However, based on the available information a definitive root cause could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - 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 deployment procedure for arterial anastomosis through an upper arm fistula, the stent graft allegedly failed to deploy.It was further reported that the proximal end of the device near the handle broke.A balloon angioplasty was then used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this 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 reported to date for this lot number and failure mode.Investigation summary: one flair endovascular stent graft was returned for evaluation.Two electronic photos were provided.The visual inspection and photos identified a break in the outer catheter.Stretching was identified on both sides of the outer catheter break.The coiled portion of the catheter was found to be bent approximately 6.7cm from the strain relief.The distal tip of the outer catheter was slightly deformed.Bunching of the outer catheter just proximal of the marker band was identified.The stent graft was in place and not released.Complete functional testing was unable to be performed due to the catheter break.The investigation is confirmed for break, failure to deploy, and material deformation.The stent graft ultimately could not be deployed because the outer catheter broke.It is possible that the user experienced high frictional deployment forces which led to the outer catheter break and deformation of the catheter.High deployment forces and increased friction may be caused be a difficult patient anatomy, insufficient flushing of the device prior to use as well as use of inadequate accessories.However, based on the available information a definitive root cause could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLAIR 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 Key7954212
MDR Text Key123373982
Report Number2020394-2018-01896
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008783
UDI-Public(01)04049519008783
Combination Product (y/n)N
PMA/PMN Number
P060002
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 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFAF07040
Device Catalogue NumberFAF07040
Device Lot NumberANBR3651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2018
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-