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

Model Number	FEM08080
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.The malfunction was reviewed and indicated that model fem08080 endovascular stent graft allegedly experienced a fracture and a break.The information was received from one source.The malfunction involved a patient with no known impact to the patient.The 53 year old male patients weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model fem08080 endovascular stent graft allegedly experienced a fracture and a break.The information was received from one source.The malfunction involved a patient with no known impact to the patient.The 53 year old male patient weight was not provided.
Additional Manufacturer Narrative
H10: out of the reported one malfunction, the device was returned for evaluation.Based on the investigation of the returned catheter sample it was confirmed that the outer sheath was fractured.A definitive 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.

• 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: 9941564
• Report Number: 2020394-2020-02528
• Device Sequence Number: 3775708
• Product Code: PFV
• UDI-Device Identifier: 04049519008509
• UDI-Public: (01)04049519008509
• 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): 06/22/2020

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: FEM08080
• Device Catalogue Number: FEM08080
• Device Lot Number: ANBQ1715
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/22/2020
• Patient Sequence Number: 1