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

Model Number FEM07080

Device Problems Fracture (1260); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A stent delivery system was returned for evaluation.The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.Upon investigation the safety clip was missing.The tuohy borst valve was found opened and the 2-way stopcock was found closed.The outer sheath was found to be fractured 39mm distal to the handle.Furthermore the outer sheath was found to be elongated.The stent graft was found to be partially deployed for 13mm.During evaluation testing the delivery system could be flushed without issue and a device compatible guide wire could be advanced through the system.A deployment test could not be performed due to the fractured outer sheath.Based on the evaluation of the sample no indication for a manufacturing related cause could be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported issue could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem07080 endovascular stent graft allegedly detached, partially deployed, and fractured.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem07080 endovascular stent graft allegedly detached, partially deployed, and fractured prior to insertion in the patient.There was no patient contact.This information was received from one source.Patient age, weight, and gender were not provided.

Manufacturer Narrative

H10: a stent delivery system was returned for evaluation.The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.Upon investigation the safety clip was missing.The tuohy borst valve was found opened and the 2-way stopcock was found closed.The outer sheath was found to be fractured 39mm distal to the handle.Furthermore the outer sheath was found to be elongated.The stent graft was found to be partially deployed for 13mm.During evaluation testing the delivery system could be flushed without issue and a device compatible guide wire could be advanced through the system.A deployment test could not be performed due to the fractured outer sheath.The investigation is confirmed for fracture and misfire.Based on the evaluation of the sample no indication for a manufacturing related cause could be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported issue could not be determined.The device is labeled for single use.H10: g4 h11: b5, g1, h6(patient code) 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: 8798818
• MDR Text Key: 151338272
• Report Number: 2020394-2019-01562
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008455
• UDI-Public: (01)04049519008455
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM07080
• Device Catalogue Number: FEM07080
• Device Lot Number: ANBZ0210
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1