MAUDE Adverse Event Report: BARD LIFE STENT; VASCULAR STENT SYSTEM

Model Number SOLO

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

Stent did not deploy from the delivery system during the procedure as expected.Pt with sfa, popliteal and tibial occlusion and stenosis.All reopened successfully and predilated with 2 mm balloon followed by a 3 mm balloon.Distal sfa/ak popliteal lesion also treated with a 4 mm dcb and 6 x 200 stent planned to be deployed overlapping part of the distal sfa / ak pop lesion that was treated in the area treated with dcb.First 3 clicks deployed and the proximal 1.5 cm of the stent deployed.The remainder of the clicks produced no further deployment of the stent.The stent was removed and a new stent placed.No pt harm.

• Brand Name: LIFE STENT
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): BARD
• MDR Report Key: 8106169
• MDR Text Key: 128598913
• Report Number: 8106169
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2020
• Device Model Number: SOLO
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCW0048
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2018
• 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: 83 YR
• Patient Weight: 66