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

Model Number	FEM06080
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
For the reported event, lot number was provided, and lot history review being performed.The sample was returned for evaluation and an x-ray image was provided and is currently underway review.The company is still investigating the issue at this time.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 fem06080 endovascular stent graft allegedly experienced positioning failure and fracture.The information was received from one source.One patient was involved with no reported injury.The male patient was (b)(6) years old and weight was not provided.
Additional Manufacturer Narrative
H10: the lot no for the device was provided, therefore a lot history review was performed.The sample was returned for evaluation and an x-ray image was provided for review.The investigation is confirmed for the positioning failure and fracture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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.
Event or Problem Description
This report summarizes one malfunction, a review of the reported information indicated that model fem06080 endovascular stent graft allegedly experienced positioning failure and fracture.The information was received from one source.One patient was involved with no reported injury.The male patient was 64 years old and weight 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: 10272248
• Report Number: 2020394-2020-04432
• Device Sequence Number: 16967556
• Product Code: PFV
• UDI-Device Identifier: 04049519008400
• UDI-Public: (01)04049519008400
• 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: FEM06080
• Device Catalogue Number: FEM06080
• Device Lot Number: ANDT4038
• 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