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

Model Number FEL08060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Partial deployment, material perforation and misfire was confirmed for the device.A root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model (b)(4) endovascular stent graft allegedly experienced failure to deploy, material perforation, and mifire.This report was received from a single source.This event did involve patient with no reported patient injury.The patients 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: 9941356
• MDR Text Key: 189115176
• Report Number: 2020394-2020-02513
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008141
• UDI-Public: (01)04049519008141
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEL08060
• Device Catalogue Number: FEL08060
• Device Lot Number: ANBY2036
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1