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

Model Number	FEM12080
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
Two lot numbers were reported for the two malfunctions and lot history reviews were performed.The devices were returned for both malfunctions, and one also returned an x-ray image.One malfunction confirmed for misfire and material perforation.The second malfunction identified material perforation.A root cause could not be determined.The devices are labeled for single use.
Event or Problem Description
This reported summarizes two malfunctions.The malfunctions were reviewed and indicated that model fem12060 endovascular stent graft allegedly experienced misfire and material perforation.This information was received from various sources.The malfunctions involved both patients with no known impact to the patients.One patient was (b)(6) year old male weighing (b)(6) kgs.The second patient was (b)(6) year old male weighing (b)(6) lbs.

• Brand Name: FLUENCY PLUS ENDVASCULAR STENT GRAFT
• Common Device Name: ENDVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9957287
• Report Number: 2020394-2020-02650
• Device Sequence Number: 14036971
• Product Code: PFV
• UDI-Device Identifier: 04049519008653
• UDI-Public: (01)04049519008653
• 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
• Report Date (Section B): 04/14/2020

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: FEM12080
• Device Catalogue Number: FEM12060
• Device Lot Number: ANDU3006, ANDR1785
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1