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

Model Number	FEM12040
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.A lot history review was performed.The investigation was confirmed for difficult or delayed positioning, fracture, positioning failure, and material perforation.A root cause could not be determined.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the information indicated that model fem12040 endovascular stent graft allegedly was difficult to deploy, failed to deploy, material perforation, and fractured.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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: 9187901
• Report Number: 2020394-2019-03903
• Device Sequence Number: 3643459
• 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
• 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: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANAU1252
• 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