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

Catalog Number	FAF08050
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2016
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 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 or Problem Description
It was reported that during deployment of an endovascular stent graft in the axillary vein, the stent graft allegedly moved forward to an unintended location.Another stent graft was used to complete procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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 event reported to date for this lot number and failure mode.Visual inspection: the sample was returned with the device packaging and label.The safety clip was missing upon receipt.The tuohy borst valve was loose and the two-way stop cock was open.The stent graft was deployed from the system and not returned.No anomalies were noted to the returned delivery system.Functional/performance evaluation: functional testing could not be performed, as the delivery system was returned with the stent graft deployed.Conclusion: the device was returned.No images were provided.The investigation was inconclusive for unintended movement, as the delivery system was returned with the stent graft deployed and no anomalies noted to the system.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: stent graft size selection: special care must be taken to ensure that the appropriate size flair endovascular stent graft is selected.The stent graft body diameter should be approximately 1 mm larger than the synthetic av access graft diameter.Indication for use: the flair endovascular stent graft is indicated for use in the treatment at the venous anastomosis of eptfe or other synthetic arteriovenous (av) access grafts.Precautions: the safety and effectiveness of this device have not been established when used around a tight bend in a looped av graft.It is recommended to access the av graft at the venous side of the av graft or at the apex.Careful attention should be paid to ensure the device is appropriately sized to the actual graft diameter, taking into account any change to the stated graft diameter that may have resulted from previous interventions.The appropriate length device(s) should be selected so that the stent graft extends beyond the stenosis into at least 10 mm of the non-diseased graft towards the arterial inflow and into the non-diseased vein approximately 10 mm beyond the stenosis.During deployment of the stent graft, the entire length of the delivery system should be kept as straight as possible in order to mitigate the potential for distal stent graft misplacement.After full stent graft deployment, wait a few seconds to allow for complete device expansion before removing the delivery system over the guidewire.Stent graft dislodgement has been reported during removal of the delivery system; therefore, careful attention should be paid during this portion of the procedure to prevent such occurrences.In case of placement of two stent grafts (overlap), use the same device diameter in both cases.If a flared device is used to overlap, do not deploy the flared end inside the first stent graft.Ensure a minimum 10 mm overlap of the devices.Potential complications and adverse events: stent graft specific events that could be associated with clinical complications include stent graft misplacement, stent graft migration, stent graft fracture, stent graft kinking, insufficient stent graft expansion and stent graft embolism.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 deployment of an endovascular stent graft in the axillary vein, the stent graft allegedly moved forward to an unintended location.Another stent graft was used to complete procedure.There was no reported patient injury.

• 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: 6063565
• Report Number: 2020394-2016-01011
• Device Sequence Number: 10872840
• Product Code: MIH
• UDI-Device Identifier: 04049519008837
• UDI-Public: (01)04049519008837(17)190226(10)ANAP3852
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060002/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2016

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 Expiration Date: 02/26/2019
• Device Catalogue Number: FAF08050
• Device Lot Number: ANAP3852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR