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

Model Number	FEM14060
Medical Device Problem Codes	Positioning Failure (1158); 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 lot number was provided; therefore, a lot history review is currently being performed.The sample was 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 indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The (b)(6) year old female patient weighed (b)(6) lbs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 77 year old female patient weighed 254 lbs.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.Based on the investigation of the returned catheter sample it was confirmed for failure to deploy/partial deployment of stent graft and material perforation.However, based on the available information, a definite root cause for the reported event could not be determined.The device is labeled for single use.H10: g4 h11: g1,h2,h6 (result & 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 indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 77 year old female patient weighed 254 lbs.
Additional Manufacturer Narrative
H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.H10: the lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

• 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: 9957295
• Report Number: 2020394-2020-02648
• Device Sequence Number: 2334115
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• 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): 06/25/2020

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: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANDW3443
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 06/18/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 04/21/2020; 06/25/2020
• Patient Sequence Number: 1