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

Model Number	FEM09120
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review will be performed.The return of the sample is pending and the investigation for the reported event is currently underway.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem09120 fluency plus endovascular stent graft allegedly experienced positioning failure.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem09120 fluency plus endovascular stent graft allegedly experienced positioning failure.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review will be performed.The sample was returned and the investigation is confirmed for partially deploy the stent graft and fracture.A root cause has not been determined.The device was labeled for single use.

• 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: 10272347
• Report Number: 2020394-2020-04433
• Device Sequence Number: 19656767
• Product Code: PFV
• UDI-Device Identifier: 04049519008578
• UDI-Public: (01)04049519008578
• 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,Followup
• Report Date (Section B): 10/08/2020

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: FEM09120
• Device Catalogue Number: FEM09120
• Device Lot Number: ANBU0969
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1