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

Model Number FEM14060

Device Problems Positioning Failure (1158); Material Perforation (2205); 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 is currently being performed.The sample was returned to bd 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 indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The (b)(6) year old female patient weighed (b)(6) lbs.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 77 year old female patient weighed 254 lbs.

Manufacturer Narrative

H10: the lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.Based on the investigation of the returned catheter sample it was confirmed for failure to deploy/partial deployment of stent graft and material perforation.However, based on the available information, a definite root cause for the reported event could not be determined.The device is labeled for single use.H10: g4 h11: g1,h2,h6 (result & conclusion) 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 indicates that model fem14060 endovascular stent graft experienced a positioning failure.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 77 year old female patient weighed 254 lbs.

Manufacturer Narrative

H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.H10: the lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

• 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: 9957295
• MDR Text Key: 187719550
• Report Number: 2020394-2020-02648
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2020

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: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANDW3443
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/21/2020; 06/18/2020
• Supplement Dates FDA Received: 04/21/2020; 06/25/2020
• Patient Sequence Number: 1