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

Model Number FEM08060

Device Problems Break (1069); Positioning Failure (1158); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem08060 endovascular stent graft allegedly experienced positioning failure.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender were not provided for the patient.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem08060 endovascular stent graft allegedly experienced positioning failure.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender were not provided for the patient.

Manufacturer Narrative

H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was returned for evaluation and the investigation confirmed for strut perforation.A definitive root cause could not be determined.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• MDR Report Key: 9941443
• MDR Text Key: 189154569
• Report Number: 2020394-2020-02524
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

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: FEM08060
• Device Catalogue Number: FEM08060
• Device Lot Number: ANCR1638
• Date Manufacturer Received: 06/18/2020
• Patient Sequence Number: 1