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

Model Number FEM14080

Device Problems Positioning Failure (1158); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The sample was returned for evaluation.The investigation is confirmed for the alleged deployment and misfire issues.The root cause could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model fem14080, endovascular stent graft, allegedly experienced misfire and failure to deploy.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• 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: 9957286
• MDR Text Key: 187708789
• Report Number: 2020394-2020-02647
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008707
• UDI-Public: (01)04049519008707
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM14080
• Device Catalogue Number: FEM14080
• Device Lot Number: ANDV3183
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1