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

Model Number	FEM10120
Medical Device Problem Codes	Failure to Reset (1532); 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 history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.Based on the investigation of the returned catheter sample an outer sheath fracture leading to a partial deployment could be confirmed.The system was found in activated condition and the sheath was found fractured with elongation at the fracture site which led to the conclusion that increased friction / release force affected the system when the stent graft was partially deployed.Removal difficulty was considered a consequence of the sheath fracture.System bend as malfunction could not be confirmed.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model fem10120 endovascular stent graft allegedly experienced material deformation, fractured, misfired, and had retraction problems.This report was received from one source.The event involved a patient with no known impact to the patient.The patients gender, age and weight 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: 9192289
• Report Number: 2020394-2019-03937
• Device Sequence Number: 3660484
• Product Code: PFV
• UDI-Device Identifier: 04049519008622
• UDI-Public: (01)04049519008622
• 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): 10/15/2019

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: FEM10120
• Device Catalogue Number: FEM10120
• Device Lot Number: ANDQ2649
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1