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

Model Number FEM14060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device for the one malfunction is expected to be 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 indicated that model fem14060 endovascular stent graft allegedly experienced material perforation and misfire.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem14060 endovascular stent graft allegedly experienced material perforation and misfire.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.The investigation is currently underway.The device is labeled for single use.H10: g4 h11: g1 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 fem14060 endovascular stent graft allegedly experienced material perforation and misfire.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation.The investigation is confirmed for the material perforation and partial deployment.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4.H11: h6 (results, 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.

• 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: 9957288
• MDR Text Key: 187708892
• Report Number: 2020394-2020-02649
• 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: 10/07/2020

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: ANDU3997
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/19/2020; 09/30/2020
• Supplement Dates FDA Received: 06/19/2020; 10/07/2020
• Patient Sequence Number: 1