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

Model Number	FAS07050
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a stent graft deployment procedure to treat anastomosis of a graft in the left upper extremity, the stent graft allegedly failed to deploy.Another device was used to complete the procedure.There was no reported patient injury.
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 1.5mm from the tip of the outer catheter.Stretching of the outer catheter was observed approximately 54mm from the strain relief.Based on the returned sample condition, the investigation is confirmed for partial deployment.It is unknown if the user flushed prior advancement/deployment or whether the patient anatomy was tortuous.Lack of flushing and tortuous anatomy could contribute to deployment issues.However, the definitive root cause is unknown.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 to treat anastomosis of a graft in the left upper extremity, the stent graft allegedly failed to deploy.Another device was used to complete the 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: 8236358
• Report Number: 2020394-2018-02304
• Device Sequence Number: 1748357
• Product Code: PFV
• UDI-Device Identifier: 04049519008950
• UDI-Public: (01)04049519008950
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: FAS07050
• Device Catalogue Number: FAS07050
• Device Lot Number: ANCV0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR