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

Model Number	FEM08120
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Occlusion Within Device (1423)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
Event or Problem Description
It was reported that a stent graft was deployed to cover up an extravasation of the cephalic arch; however, a hole was allegedly identified on the coating of the stent graft and contrast was seen leaking from the vessel where the stent graft was placed.It was further reported that the guidewire was seen protruding through the stent graft.The patient returned two days later and the eptfe allegedly had torn and created a flap, causing thrombus within the stent graft.This resulted in another stent graft deployment inside of the previous stent graft, overlapping technique to open the vessel.The procedure was concluded and he patient was reported as stable.

• 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: 7430943
• Report Number: 2020394-2018-00389
• Device Sequence Number: 11253538
• Product Code: PFV
• UDI-Device Identifier: 04049519008523
• UDI-Public: (01)04049519008523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FEM08120
• Device Catalogue Number: FEM08120
• Device Lot Number: ANBZ2755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention