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

Model Number	FEM07060
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The corporate lot number of the device was provided and lot history is reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 fem07060 endovascular stent graft allegedly broke and experienced position failure.This information was received from one source.The alleged malfunction had patient involvement however there were no patient consequences.The age, weight and gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the corporate lot number of the device was provided and lot history was reviewed.The device was been returned to the manufacturer for evaluation.Investigation of the device confirmed the outer sheath fracture which made deployment impossible.Based on the available information, a definite root cause could not be determined.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem07060 endovascular stent graft allegedly broke and experienced position failure.This information was received from one source.The alleged malfunction had patient involvement however there were no patient consequences.The age, weight and gender of the patient was 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: 10299554
• Report Number: 2020394-2020-04688
• Device Sequence Number: 3853575
• Product Code: PFV
• UDI-Device Identifier: 04049519008448
• UDI-Public: (01)04049519008448
• 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): 10/19/2020

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: FEM07060
• Device Catalogue Number: FEM07060
• Device Lot Number: ANDX1908
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1