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

Model Number	FEM10120
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); 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 for the device was provided.The sample was returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem10120 endovascular stent graft alleged difficult to deploy, misfire, sheath fracture and partial deployment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient's age and weight were unknown.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem10120 endovascular stent graft alleged difficult to deploy, misfire, sheath fracture and partial deployment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient's age and weight were unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for partial deployment, sheath fracture and difficult to deploy.However, the investigation is unconfirmed failure to expand.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4, h6 (device: 3270).H11: h6 (results, conclusion).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: 10289548
• Report Number: 2020394-2020-04614
• Device Sequence Number: 11337072
• 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,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: FEM10120
• Device Catalogue Number: FEM10120
• Device Lot Number: ANDV0191
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1