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

Model Number FEM12060

Device Problems Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A lot number was provided so a lot history review will be performed.The device was returned to bd for evaluation.The investigation identified for material perforation, but it is still investigating the misfire 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 a misfire and material perforation.This information was received from one source.This malfunction did involve patients with no reported patient injury.The male patient's age and weight were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly experienced a misfire and material perforation.This information was received from one source.This malfunction did involve patients with no reported patient injury.The male patient's age and weight were not provided.

Manufacturer Narrative

H10: a lot number was provided so a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed misfire and material perforation.Based upon the available information, a definitive root cause is unknown.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: 9571296
• MDR Text Key: 180330383
• Report Number: 2020394-2020-00153
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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: ANCS2367
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1