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

Model Number	FEM06100
Medical Device Problem Codes	Break (1069); 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 history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Increased friction and high deployment force may be associated with a difficult patient anatomy or a challenging placement site.Insufficient flushing of the device prior to use may be a contributing factor.In this case the patient anatomy was predilated and the delivery system was flushed prior to use.The patient anatomy was not tortuous or calcified.However, as reported advancing difficulties were present.It was also alleged that the tuohy borst valve was broken which could be another consequence of high friction during deployment.However, during sample evaluation it was identified that the tuohy borst valve was unscrewed and could be reattached to the system.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported issue could not be determined.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem06100.Endovascular stent graft allegedly experienced break, failure to deploy, fracture, misfire, and difficult to advance.This report was received from a single source.This event did involve patient with no reported patient injury.The patients 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: 8785583
• Report Number: 2020394-2019-01484
• Device Sequence Number: 11347537
• Product Code: PFV
• UDI-Device Identifier: 04049519008417
• UDI-Public: (01)04049519008417
• 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): 07/12/2019

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: FEM06100
• Device Catalogue Number: FEM06100
• Device Lot Number: ANBY2032
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/12/2019
• Patient Sequence Number: 1