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

Model Number	FEM09080
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the reported malfunctions as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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 fem09080 endovascular stent graft allegedly experienced failure to deploy, positioning issue, and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6)female patient was (b)(6) lb.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.The investigation was confirmed for misfire.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4, h6 (device codes: 2532 - misfire).H11: h6 (method, 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 fem09080 endovascular stent graft allegedly experienced failure to deploy, positioning issue, and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 75 year old female patient was 165 lb.

• 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: 9570560
• Report Number: 2020394-2020-00134
• Device Sequence Number: 10872314
• Product Code: PFV
• UDI-Device Identifier: 04049519008554
• UDI-Public: (01)04049519008554
• 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): 04/03/2020

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: FEM09080
• Device Catalogue Number: FEM09080
• Device Lot Number: ANDS4368
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1