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

Model Number	FEM08040
Medical Device Problem Codes	Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole complaint is expected to be returned to bd 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 fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample has been returned for evaluation.The investigation for the returned sample is confirmed for material perforation and partial deployment (misfire).Based on the available information, the root cause could not be determined.The device is labeled for single use.H10: g4 h11: h6 (device codes) 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 fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample has been returned for evaluation.The evaluation identified the stent graft was partially deployed (misfire).Based on the available information, the 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 fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age 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: 9187837
• Report Number: 2020394-2019-03902
• Device Sequence Number: 16759351
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486
• 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,Followup
• Report Date (Section B): 04/02/2020

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: FEM08040
• Device Catalogue Number: FEM08040
• Device Lot Number: ANDR0784
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 03/31/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 01/07/2020; 04/02/2020
• Patient Sequence Number: 1