MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY ENDOVASCULAR STENT GRAFT; SYSTEM, ENDO GRAFT, (AV) DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Model Number FEM14120

Device Problems Stretched (1601); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

While bard fluency stent was being deployed in the left iliac artery, the stent delivery sheath "stretched" considerably thus not allowing the entire stent to deploy.Vendor representation was present for the entire case to assist with fluency stent.Vendor was unable to recommend ideas for the situation and unable to get in touch with their engineer.Surgeons were called for possible emergent surgery extraction as well as vascular ir attending for advice.Decision was made to cut through the fluency delivery sheath in order to manually deploy stent via de-sheathing.Stent deployed, but a second stent had to be placed to cover an area missed due to malfunction.Device was intact after removal (stent deployed in iliac).Manufacturer response for system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment, fluency® endovascular stent graft (per site reporter) bard representative onsite during this procedure and aware of issue in the moment.

• Brand Name: FLUENCY ENDOVASCULAR STENT GRAFT
• Type of Device: SYSTEM, ENDO GRAFT, (AV) DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 14696355
• MDR Text Key: 294379730
• Report Number: 14696355
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2022,05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM14120
• Device Catalogue Number: FEM14120
• Device Lot Number: ANFW1815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White