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

Model Number	FAF07050
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 shuntogram stent graft placement of the upper arm, the stent graft allegedly could not be fully deployed.It was further reported that the delivery system and stent graft were removed from the sheath without issue.The procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 one flair endovascular stent graft was returned for evaluation.Visual inspection noted the stent was partially deployed.During guidewire patency test, the guidewire was advanced through the catheter with resistance past the incidental bends.The stent was also able to be fully deployed without issue.Therefore, the investigation is confirmed for partial deployment as the system was returned with the stent extending past the outer catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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 shuntogram stent graft placement of the upper arm, the stent graft allegedly could not be fully deployed.It was further reported that the delivery system and stent graft were removed from the sheath without issue.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: 7558997
• Report Number: 2020394-2018-00769
• Device Sequence Number: 13511078
• Product Code: PFV
• UDI-Device Identifier: 04049519008790
• UDI-Public: (01)04049519008790
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/18/2018

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 Expiration Date: 02/09/2018
• Device Model Number: FAF07050
• Device Catalogue Number: FAF07050
• Device Lot Number: ANCN3394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1