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

Model Number FEM12060

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number of 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 fem12060 endovascular stent graft allegedly experienced positioning failure and fracture.This information was received from one source.One patient was involved with no patient consequences.The (b)(6) year old female patient was (b)(6) lbs.

Manufacturer Narrative

H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Deployment failure was confirmed for the device.A root cause has not been determined.The device was labeled for single use.H10: g4 h11: g1, g7, h6 (result, conclusion), b5 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly experienced positioning failure and fracture.This information was received from one source.One patient was involved with no patient consequences.The patient is 61years old, female and 160lbs.

• 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: 9957508
• MDR Text Key: 187559586
• Report Number: 2020394-2020-02651
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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

• 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: ANCQ3729
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 06/19/2020
• Patient Sequence Number: 1