MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT

Model Number	FAF07040
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7954212
• Report Number: 2020394-2018-01896
• Device Sequence Number: 11332807
• Product Code: PFV
• UDI-Device Identifier: 04049519008783
• UDI-Public: (01)04049519008783
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: FAF07040
• Device Catalogue Number: FAF07040
• Device Lot Number: ANBR3651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 01/11/2019
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/03/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1