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

Model Number	FAF08050
Medical Device Problem Codes	Positioning Failure (1158); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stent graft was returned.The stent graft was returned partially deployed approximately 9mm from the tip of the outer catheter.Stretching of the outer catheter was observed approximately 52mm from the strain relief.Material separation was noted as the eptfe was separated from several struts near the distal end of the partially deployed stent graft.Based on the returned sample condition, the investigation is confirmed for partial deployment and material separation.The stretching of the outer catheter and separation of eptfe are indicative of excessive force applied in an attempt to deploy the stent graft.The root cause of the partial stent graft deployment could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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 the endovascular stent graft allegedly would not deploy in the brachial vein via an upper arm graft access site.Reportedly, the stent graft delivery system was removed without incident and the procedure was completed with another device.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: 8091234
• Report Number: 2020394-2018-02102
• Device Sequence Number: 1458709
• Product Code: MIH
• UDI-Device Identifier: 04049519008837
• UDI-Public: (01)04049519008837
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: FAF08050
• Device Catalogue Number: FAF08050
• Device Lot Number: ANBR3654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/20/2018
• 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