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

Model Number	FEM12060
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device(s) has been returned for evaluation; the evaluation confirmed a failure to deploy, misfire, retraction issues, and material perforation by a graft strut.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly experienced failure to deploy, retraction problems, material perforation, and misfiring.This information was received from one source.One patient was involved with no patient consequences.The patient was a (b)(6) year old male weighing (b)(6) pounds.

• 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: 9188646
• Report Number: 2020394-2019-03915
• Device Sequence Number: 14363205
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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
• Report Date (Section B): 10/14/2019

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: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANCV4633
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1