MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) FLAIR ENDOVASCULAR STENT GRAFT

Model Number	FAF07050
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.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 faf07050 flair endovascular stent graft allegedly experienced retraction problem.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient's age and weight was unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed the break; however, the investigation is inconclusive for retraction problem.A definitive root cause for the reported event could not be determined.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model faf07050 flair endovascular stent graft allegedly experienced retraction problem.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient's age and weight was unknown.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV)
• MDR Report Key: 10286808
• Report Number: 2020394-2020-04553
• Device Sequence Number: 515446
• Product Code: PFV
• UDI-Device Identifier: 04049519008790
• UDI-Public: (01)04049519008790
• 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): 10/15/2020

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: FAF07050
• Device Catalogue Number: FAF07050
• Device Lot Number: ANBZ1240
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1