MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFE STENT; VASCULAR STENT SYSTEM

Model Number BILIART

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2018

Event Type  malfunction  

Event Description

Stent did not deploy from the delivery system during the procedure as expected.Procedure was being performed for a left common iliac artery stenosis for left lower extremity claudication.Bilateral femoral access was obtained as the stenosis involved the origin of the left common iliac artery.The stent was advanced via the left femoral access sheath to the aortic bifurcation and deployed from the level of the aortic bifurcation shown to the distal left common iliac artery.The stent would not dislodge from the delivery system.Subsequently as the delivery system was attempted to be removed, the distal aspect of the stent became lodged in the sheath.It appeared that there was a malfunction of the delivery system itself.The deployment mechanism had become jammed in the deployment handle.The deployment mechanism was fully deployed by manually grasping it with a hemostat and pulling it towards the end of the handle.This allowed the stent to dislodge from the delivery system.The delivery system was able to be withdrawn.The stent was then deployed from the 6 french bright tip sheath by cutting off the dilator of the 6 french sheath and advancing it over the rosen wire to the end of the stent and forcing the remaining aspect of the stent to deploy.The stent was then once again post-dilated with a 7 mm balloon.The right common iliac artery origin was dilated with a 7 mm balloon as well.There was a nonflow limiting dissection beginning at the left iliac bifurcation and extending into the left common femoral artery, and this was dilated from the contralateral side using a 6mm balloon.We used a star close device to remove the left femoral access sheath.The pt was admitted overnight for observation and discharged home the next day.The pt was seen at a f/u appt and had no post procedure complications.

• Brand Name: LIFE STENT
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 8106148
• MDR Text Key: 128598856
• Report Number: 8106148
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Model Number: BILIART
• Device Catalogue Number: EX080601CD
• Device Lot Number: ANCS2239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2018
• Distributor Facility Aware Date: 11/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 105