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

Catalog Number	FAF09040
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2013
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 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 not 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 a stent graft deployment in the brachial vein, the flared end of the stent graft did not completely open.No further intervention was performed.There is no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: three fluoroscopic images were reviewed.The stent graft is visible proximal to another stent in the brachial vein in a right arm.Contrast is visible in one image.The stent graft appears to be uniformly expanded from the proximal to the distal end.The distal end of the stent graft does not exhibit a flared appearance.No images of the vessel prior to stent graft implantation were provided.Based on the images provided, failure of the distal end of the stent graft to completely expand (flare) can be confirmed.Conclusion:although the device was not returned for evaluation, images were provided for review.Based on the images provided, the investigation is confirmed for failure to expand as the distal end of the stent graft did not exhibit a flared appearance.Labeling review: the current instructions for use (ifu)provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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.

• 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: 5352391
• Report Number: 2020394-2016-00006
• Device Sequence Number: 632502
• Product Code: MIH
• UDI-Device Identifier: 04049519008998
• UDI-Public: (01)04049519008998(10)ANVC3064
• 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
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 04/19/2013

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: 03/31/2014
• Device Catalogue Number: FAF09040
• Device Lot Number: ANVC3064
• Was Device Available for Evaluation?: No
• 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: 01/07/2016
• 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