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

Model Number	FAF07070
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The lot history review will be performed.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This event summarizes one malfunction.The information reviewed indicated that model faf07070 endovascular stent graft allegedly experienced a break, detachment of device/device component, and difficult to remove.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient injury.
Event or Problem Description
This event summarizes one malfunction.The information reviewed indicated that model faf07070 endovascular stent graft allegedly experienced a break, detachment of device/device component, and difficult to remove.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: for the reported malfunction, a corporate lot number was provided and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation identified the alleged break and detachment of device-device component but was inconclusive for difficult to remove.The definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.

• 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: 9214239
• Report Number: 2020394-2019-04131
• Device Sequence Number: 2388157
• Product Code: PFV
• UDI-Device Identifier: 04049519008806
• UDI-Public: (01)04049519008806
• 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): 01/08/2020

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: FAF07070
• Device Catalogue Number: FAF07070
• Device Lot Number: ANBN1425
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1