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

Model Number	FAF08050
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model faf08050 endovascular stent graft allegedly experienced migration of device.This information was received from one source.The malfunction involved a patient with no consequences.The age and weight were not reported for the patient involved.The reported patient was male.
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The sample was returned for evaluation and the investigation is inconclusive for the alleged stent migration.A definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model faf08050 endovascular stent graft allegedly experienced migration of device.This information was received from one source.The malfunction involved a patient with no consequences.The age and weight were not reported for the patient involved.The reported patient was male.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8783171
• Report Number: 2020394-2019-01474
• Device Sequence Number: 1845803
• Product Code: PFV
• UDI-Device Identifier: 04049519008837
• UDI-Public: (01)04049519008837
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: No Information
• Device Model Number: FAF08050
• Device Catalogue Number: FAF08050
• Device Lot Number: ANAW1233
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1