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

Model Number	FEM12040
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205); Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for the one malfunction.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 fem12040 endovascular stent graft allegedly experienced failure to deploy, material perforation and deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction and a lot history review was completed.The device was returned for the one malfunction and the evaluation confirmed for positioning failure, misfire, and material perforation.A root cause was not 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: fem12040 endovascular stent graft allegedly experienced positioning failure, material perforation and misfire.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.

• 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: 9583856
• Report Number: 2020394-2020-00194
• Device Sequence Number: 18914196
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639
• 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): 04/02/2020

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: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANDW2143
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1