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

Model Number	FEM08100
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)
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 malfunction 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 fem08100 endovascular stent graft allegedly experienced a break, failure to deploy, and detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported patient consequence.The patient was reported as a (b)(6) male weighing (b)(6) lbs.
Additional Manufacturer Narrative
H10: a voluntary recall was issued for the max-core disposable core biopsy instrument for specific product code/lot number combinations.The affected product code/lot number combinations may be at risk of having firing issues.An example of a firing issue is where the device does not completely fire, resulting in the inability to obtain tissue samples.A root cause investigation and field action determination was conducted as a result of an increase in complaints for failure to fire, firing problem, and failure to obtain samples.The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices.The root cause for the increase in complaints was related to mold maintenance that was performed on the cannula over-mold for mold 3.That maintenance had the unintended consequence of impacting product performance in specific low frequency use situations.The change made to mold 3 increased the spacing between the locking and unlocking mechanisms of the device, resulting in a reduction in stored energy within the device.This, in combination with the density of the tissue being biopsied, can occasionally result in issues where the device does not fully fire when the trigger is pressed (i.E.Only the stylet fires).All lots manufactured after the maintenance on mold 3 was performed are included in the scope of the recall.All reported complaints from the affected product code/lot number combinations that are possibly related to the firing issue have been classified as failure to fire, firing problem, or failure to obtain samples.This reported complaint is from an affected lot number that was reported for one of these firing issues.H10: d4 expiry date (02/2022), g4 h11: 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 fem08100 endovascular stent graft allegedly experienced a break, failure to deploy, and detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported patient consequence.The patient was reported as a 65-year-old male weighing 186 lbs.

• 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: 9570385
• Report Number: 2020394-2020-00131
• Device Sequence Number: 16897238
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516
• 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): 04/16/2020

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: FEM08100
• Device Catalogue Number: FEM08100
• Device Lot Number: ANDT2831
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1