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

Model Number	FEM06080
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
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 has been returned for evaluation based on the investigation of the returned catheter sample it was confirmed that the user could only partially deploy the stent graft.Based upon the available information, the definitive root cause is unknown.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 fem06080 endovasculr stent graft allegedly experienced failure to deploy and a misfire.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient's weight was not provided.

• Brand Name: FLUENCY PLUS ENDOVASCULR STENT GRAFT
• Common Device Name: ENDOVASCULR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9189086
• Report Number: 2020394-2019-03927
• Device Sequence Number: 2448951
• Product Code: PFV
• UDI-Device Identifier: 04049519008400
• UDI-Public: (01)04049519008400
• 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: FEM06080
• Device Catalogue Number: FEM06080
• Device Lot Number: ANCT1529
• 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