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

Model Number	FAS08050
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 placement of the vascular stent graft in the loop graft, the stent graft allegedly deployed in an unintended placement site.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed.There was no reported patient injury.
Event or Problem Description
It was reported that during placement of the vascular stent graft in the loop graft, the stent graft allegedly deployed in an unintended placement site.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed.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.The device was returned with one x-ray image.Based on the image review two stents were overlapping at the proximal radius and another two stents were overlapping at the humerus and radius.No anomalies were noted during visual inspection.The system was flushed and guidewire patency was tested without issue.No further testing was viable due to sample condition.Therefore, the investigation is inconclusive for malposition of the stent as the device was returned deployed and the returned image could not confirm the failure.Based upon the available information, the definitive root cause for malposition of the stent is unknown.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• 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: 7844058
• Report Number: 2020394-2018-01641
• Device Sequence Number: 13938302
• Product Code: PFV
• UDI-Device Identifier: 04049519008998
• UDI-Public: (01)04049519008998
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: FAS08050
• Device Catalogue Number: FAS08050
• Device Lot Number: ANCP1482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60