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

Model Number FEM12040

Device Problems Positioning Failure (1158); Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the 2 devices, both lot numbers for the devices were provided, a manufacturing review will be performed.Both samples were returned to the manufacturer for inspection/evaluation.One sample was confirmed for partial deployment, material perforation and misfire and the second sample was identified for partial deployment, material perforation and misfire.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model fem12040 endovascular stent graft allegedly experienced failure to deploy, material perforation and misfire.These reports were received from various sources.Both events did involve patients with no reported patient injury.One patient is (b)(6) years old, (b)(6) lbs., and male; however, the second patients¿ age, weight and gender was not reported.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9957792
• MDR Text Key: 187708557
• Report Number: 2020394-2020-02657
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANDV2568, ANDW2161
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1