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

Model Number	FAF07070
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 or Problem Description
It was reported that during a stent graft deployment procedure, the stent graft allegedly partially deployed.It was further reported that upon removal of the delivery system, the proximal end of the catheter was allegedly found to be broken.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 all specifications prior to shipment.No additional complaint has been reported for this lot number previously.Investigation summary: one flair endovascular stent graft was returned.The device was visually evaluated and found to have a break in the outer catheter and the stent partially deployed.Therefore, the investigation will be confirmed for break and partial deployment.Potential factors which may have caused or contributed to the reported issue have been considered.The reported type of event may be related to a difficult patient anatomy or a challenging placement site, which may have led to increased friction force during deployment.Insufficient flushing of the device or use of inadequate accessories could be a contributing factor for the reported issue.It is unknown if the device was flushed prior to use.Outer catheter stretching was identified which indicates high frictional forces.The break is likely a result of additional force applied in an attempt to deploy the stent graft.However, the definitive root cause for the reported event 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.
Event or Problem Description
It was reported that during a stent graft deployment procedure, the stent graft allegedly partially deployed.It was further reported that upon removal of the delivery system, the proximal end of the catheter was allegedly found to be broken.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft deployment procedure, the stent graft allegedly partially deployed.It was further reported that upon removal of the delivery system, the proximal end of the catheter was allegedly found to be broken.There was no reported patient injury.
Additional Manufacturer Narrative
The previously submitted supplemental emdr inaccurately reported the date of 10/22/2018.The date on the supplemental should have been reported as 01/07/2019.Manufacturing review: 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 all specifications prior to shipment.No additional complaint has been reported for this lot number previously.Investigation summary: one flair endovascular stent graft was returned.The device was visually evaluated and found to have a break in the outer catheter and the stent partially deployed.Therefore, the investigation will be confirmed for break and partial deployment.Potential factors which may have caused or contributed to the reported issue have been considered.The reported type of event may be related to a difficult patient anatomy or a challenging placement site, which may have led to increased friction force during deployment.Insufficient flushing of the device or use of inadequate accessories could be a contributing factor for the reported issue.It is unknown if the device was flushed prior to use.Outer catheter stretching was identified which indicates high frictional forces.The break is likely a result of additional force applied in an attempt to deploy the stent graft.However, the definitive root cause for the reported event 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: 7954408
• Report Number: 2020394-2018-01897
• Device Sequence Number: 427800
• Product Code: MIH
• UDI-Device Identifier: 04049519008806
• UDI-Public: (01)04049519008806
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2019

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: FAF07070
• Device Catalogue Number: FAF07070
• Device Lot Number: ANAP2822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 02/01/2019
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 01/07/2019; 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1