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

Model Number FEM14060

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definite root cause for the reported event could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem14060 fluency plus endovascular stent graft allegedly experienced misfire.This information was received from one source.This malfunction involved one 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 ; 4803032690
• MDR Report Key: 10273474
• MDR Text Key: 198855854
• Report Number: 2020394-2020-04439
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANCW2066
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1