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

Catalog Number	FAF09050
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A further clinical review of the event details was completed and a change in the mdr reportability was identified.No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been 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 a stent graft in a dialysis shunt, the outer catheter broke; however, the stent graft was deployed successfully.There was no patient injury reported.
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.Visual inspection: the system was returned used.Safety clip was missing upon receipt.The tuohy borst adapter was loose and the two-way stop cock was closed.The gray outer catheter was bent approximately 363mm from the proximal end of the handle at the catheter reinforcement area.The outer gray catheter in this area was noted to be stretched.The stent graft was found to be released and was not returned with the delivery system.The inner green catheter was noted to be kinked 65mm from the distal tip.No other anomalies were noted.Functional/performance evaluation: functional testing could not be performed, as the delivery system was returned with the stent graft deployed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is unconfirmed for an outer shaft break, as the outer catheter was returned intact with no break noted to the delivery device.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) state: 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.Warnings: the stent graft (implant) cannot be repositioned after total or partial deployment.Once partially or fully deployed, the flair endovascular stent graft cannot be retracted or remounted onto the delivery system.Device removal after deployment can only be done with a surgical approach.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.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 5355570
• Report Number: 2020394-2016-00055
• Device Sequence Number: 13556114
• Product Code: MIH
• UDI-Device Identifier: 04049519008875
• UDI-Public: (01)04049519008875(10)ANYA0935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060002/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/03/2014

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: 01/31/2017
• Device Catalogue Number: FAF09050
• Device Lot Number: ANYA0935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• Supplement Report FDA Received Date: 03/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR