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

Model Number	FEM10100
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Misfire (2532)
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.Failure deploy, fracture and misfire was confirmed.An x-ray image was provided and is currently underway review.The company is still investigating the issue at this time.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem10100.Endovascular stent graft allegedly experienced failure to deploy, misfire, and fracture.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is male, (b)(6) kgs and (b)(6) years of age.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review.The sample and an image were returned for evaluation.The investigation confirmed for failure deploy, fracture and misfire.The root cause could not be determined.The device was 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 fem10100.Endovascular stent graft allegedly experienced failure to deploy, misfire, and fracture.This report was received from a single source.This event involved a patient with no reported patient injury.The patient is male, 90 kgs and 73 years of age.

• Brand Name: FLUENCY PLUS 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: 9571297
• Report Number: 2020394-2020-00152
• Device Sequence Number: 3244525
• Product Code: PFV
• UDI-Device Identifier: 04049519008615
• UDI-Public: (01)04049519008615
• 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): 03/31/2020

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: FEM10100
• Device Catalogue Number: FEM10100
• Device Lot Number: ANDR1778
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1