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

Model Number	FEM12060
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided; therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.The company is still investigating the issue at this time.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 fem12060 endovascular stent graft allegedly experienced positioning failure and fracture.This information was received from one source.One patient was involved with no patient consequences.The (b)(6) year old female patient was (b)(6) lbs.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Deployment failure was confirmed for the device.A root cause has not been determined.The device was labeled for single use.H10: g4 h11: g1, g7, h6 (result, conclusion), b5 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 fem12060 endovascular stent graft allegedly experienced positioning failure and fracture.This information was received from one source.One patient was involved with no patient consequences.The patient is 61years old, female and 160lbs.

• 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: 9957508
• Report Number: 2020394-2020-02651
• Device Sequence Number: 16727932
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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): 06/19/2020

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: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANCQ3729
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1