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

Model Number FEM12060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the one malfunction; therefore, a lot history review has been performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is confirmed for failure to deploy and material perforation.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly experienced failure to deploy and material perforation.This information was received from one source.Of the one allegation of failure to deploy and material perforation, there was an involved patient with no patient consequences.There was no provided patient information.

• 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: 9572241
• MDR Text Key: 174536472
• Report Number: 2020394-2020-00182
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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: 01/09/2020

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
• Device Operator: No Information
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANDN0692
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/09/2020
• Type of Device Usage: N
• Patient Sequence Number: 1